Other products from "DENT ZAR, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 D836QXGZK2 1 2022 Dental burs are a vital tool required for almost every dental treatment and proc Dental burs are a vital tool required for almost every dental treatment and procedure. They are necessary for cutting, grinding, and removing hard and soft tissue and are designed to attach to the rotary dental handpiece for fast and efficient dental work. DZP Instrument, Diamond, Dental 1 Dental Diamond Burs
2 D83610141 1014 1014 • Easy to apply; fast cure.• Outstanding depth of cure.• Reliable performance.• • Easy to apply; fast cure.• Outstanding depth of cure.• Reliable performance.• Good mechanical strength and wear resistance allows for an extended service time of up to six months.• Good biocompatibility shares the same basic chemistry with light cured cavity liners.• Easy removal.• Compatible with all known permanent restoratives and cements.• Long shelf life with no need for refrigeration.• Versatility in use; also suitable for making temporary inlays and onlays, endodontic stopping and emergency temporization. EBG Crown And Bridge, Temporary, Resin Accu Light Temporary Restorative
3 D83610111 1011 1011 Light Super Bond represents state-of- the-art technology: it offers the most des Light Super Bond represents state-of- the-art technology: it offers the most desirable characteristics, in versatility, ease of handling and reliability. • Unlimited working time-cures on demand with a visible light-curing unit.• Bracket compatibility-designed to be used with ceramic, plastic or metal brackets.• Viscosity-consistency of the Light Super Bond-M paste eliminates bracket flotation.• High light sensitivity of the material allows for the use of Light Super Bond-M not only for bonding translucent (plastic or ceramic) brackets, but also for light impermeable metal ones.• Light Super Bond-M is a light cured material, which allows for relief from time pressure.• The dentist, therefore, has plenty of time for cleaning the excess adhesive around the bracket bases. • Simplicity of application procedure, and relief from time pressure, results in obtaining reproducible bond strength, and precise bracket placement.• The material has superior resistance to discoloration. It is economical to use and has virtually no waste and long shelf life, all of which contribute to the ease of working with this product. DYH Adhesive, Bracket And Tooth Conditioner, Resin 2 Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe
4 D83610051 1005 1005 Atlas is used for: final cementation of implant prosthesis, crowns, bridges, in- Atlas is used for: final cementation of implant prosthesis, crowns, bridges, in-lays, on-lays, Maryland bridges, veneers, cementation of posts and pins, pit and fissure sealants, periodontal splinting, and cementation of orthodontic bands and appliances.. OUTSTANDING FEATURES OF THE MATERIAL•Excellent handling characteristics•Dual-Cured•Fluoride release•X-ray opacity•Low irritation potential•Negligible solubility•Low film thickness•Excellent resistance to oral environment and mechanical strength assure good long-term performance•Long shelf life DYH Adhesive, Bracket And Tooth Conditioner, Resin 2 Atlas Dual Cure Cement
5 D83610050 0007 1007 Atlas is used for: final cementation of implant prosthesis, crowns, bridges, in- Atlas is used for: final cementation of implant prosthesis, crowns, bridges, in-lays, on-lays, Maryland bridges, veneers, cementation of posts and pins, pit and fissure sealants, periodontal splinting, and cementation of orthodontic bands and appliances.. OUTSTANDING FEATURES OF THE MATERIAL•Excellent handling characteristics•Dual-Cured•Fluoride release•X-ray opacity•Low irritation potential•Negligible solubility•Low film thickness•Excellent resistance to oral environment and mechanical strength assure good long-term performance•Long shelf life DYH Adhesive, Bracket And Tooth Conditioner, Resin 2 Atlas Dual Cure Cement, Single Carthridge
6 D83610041 1004 1004 Pearl is a self-cured, filled permanent cement designed for cementing convention Pearl is a self-cured, filled permanent cement designed for cementing conventional cast restorations on most vital and non-vital teeth. It also cements bonded bridges of both cast and etched (Maryland) and perforated base (Rochette) types. It is also suitable for cementing prefabricated laminate veneers, ceramic crowns, inlays, onlays, pins, posts and periodontal splinting.• Versatile.• Predictable, controllable and reproducible working time.• Excellent biological and chemical resistance to oral environment.• Excellent adhesion to both the tooth and metal surfaces.• High compressive and diametral tensile strength.• Simplicity in application. EMA Cement, Dental 2 Pearl Composite Luting Cement Syringe System
7 D83600490 0049 0049 Light Super Bond represents state-of- the-art technology: it offers the most des Light Super Bond represents state-of- the-art technology: it offers the most desirable characteristics, in versatility, ease of handling and reliability. • Unlimited working time-cures on demand with a visible light-curing unit.• Bracket compatibility-designed to be used with ceramic, plastic or metal brackets.• Viscosity-consistency of the Light Super Bond-M paste eliminates bracket flotation.• High light sensitivity of the material allows for the use of Light Super Bond-M not only for bonding translucent (plastic or ceramic) brackets, but also for light impermeable metal ones.• Light Super Bond-M is a light cured material, which allows for relief from time pressure.• The dentist, therefore, has plenty of time for cleaning the excess adhesive around the bracket bases. • Simplicity of application procedure, and relief from time pressure, results in obtaining reproducible bond strength, and precise bracket placement.• The material has superior resistance to discoloration. It is economical to use and has virtually no waste and long shelf life, all of which contribute to the ease of working with this product. DYH Adhesive, Bracket And Tooth Conditioner, Resin 2 Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe
8 D83600321 0032 0032 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin Acorn Single Dose Caps. Sh. B1
9 D83600160 0016 0016 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin 2 Acorn Nano Micro Hybrid-Syringe Shade A3.5
10 D83600100 0010 0010 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin 2 Acorn Nano Micro Hybrid-Syringe Shade A3
11 D83610011 1001 1001 Olympian M is used for cementating temporary crowns and splints. Retention of te Olympian M is used for cementating temporary crowns and splints. Retention of temporary crowns, sealing dressing in teeth during root canal therapy procedures.Trial cementation of permanent restorations prior to final insertion.Testing of interproximal contacts prior to final placement. EMA Cement, Dental Olympian M Temporary Cement Auto-Mix System
12 D83600531 0053 0053 Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula)• in dual c Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula)• in dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light.• Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode.• Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts.• Moldable, non sticky consistency.• Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure.• Contains moderately hard filler for easier carving and shaping.• Does not require refrigeration: long shelf life at ambient temperatures.• The Standard Saturn M kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics. EBF Material, Tooth Shade, Resin Saturn M Rest Paste Contrast (Two 5 g syringes)
13 D836PSLFH9 1 2023 A mains electricity (AC-powered), hand-held, device intended to be used to activ A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station. EAY Light, Fiber Optic, Dental 1 LED Curing Light
14 D83610201 1020 1020 Eagle-Dual-Cure Core Build-Up Material Auto-Mix System• Convenient working time Eagle-Dual-Cure Core Build-Up Material Auto-Mix System• Convenient working time in self-cure mode.• Light-cure properties of the material facilitate cure of the product.• Well balanced x-ray opacity permits tooth structure, pins, and posts to be easily distinguishable from material.• Does not require refrigeration; long shelf-life at ambient temperatures.• Significantly saves chair-time due to its auto-mix system.• Intra-oral tips permit application of the material directly into the tooth. EBF Material, Tooth Shade, Resin Eagle-Dual-Cured Core Build-Up Material in Auto-Mix Cartridges
15 D83610121 1012 1012 Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for an Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for anterior and posterior restorations. Material exhibits; high mechanical strength and excellent marginal adaptation. High filler content contributes to low shrinkage, low water sorption, low coefficient of thermal expansion and good wear and scratch resistance. Acclaim has a very good x-ray opacity, outstanding color stability and resistance to staining. EBF Material, Tooth Shade, Resin 2 Acclaim Chemical Cure Composite Restorative Material
16 D83610071 1007 1007 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin 2 Acorn Nano-Micro Hybrid Single Dose Capsules Kit
17 D83600590 0059 0059 • Skyrock M is a paste/liquid system.• Well-balanced x-ray opacity permits easy • Skyrock M is a paste/liquid system.• Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts.• It is moldable and non-sticky yet has an adhesive consistency.• Allows one to control consistency, wherever desirable, by adding more or less liquid.• Contains moderately hard filler for easier carving and shaping.• Does not require refrigeration: long shelf life at ambient temperatures.• Standard Skyrock M kit comes in two shades: one is contrasting, for easy distinguishing from tooth structure; the other is natural, for use under semi-transparent ceramics. EBF Material, Tooth Shade, Resin 2 Skyrock M P/L Core Build Up Material Part A Contrast, Jar
18 D83600520 0052 0052 Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for an Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for anterior and posterior restorations. Material exhibits; high mechanical strength and excellent marginal adaptation. High filler content contributes to low shrinkage, low water sorption, low coefficient of thermal expansion and good wear and scratch resistance. Acclaim has a very good x-ray opacity, outstanding color stability and resistance to staining. EBF Material, Tooth Shade, Resin 2 Acclaim Chemical Cure Composite Restorative Material Single Jar Part B
19 D83600510 0051 0051 Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for an Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for anterior and posterior restorations. Material exhibits; high mechanical strength and excellent marginal adaptation. High filler content contributes to low shrinkage, low water sorption, low coefficient of thermal expansion and good wear and scratch resistance. Acclaim has a very good x-ray opacity, outstanding color stability and resistance to staining. EBF Material, Tooth Shade, Resin 2 Acclaim Chemical Cure Composite Restorative Material Single Jar Part A
20 D83600291 0029 0029 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin Acorn Single Dose Caps. Sh.D3
21 D83600301 0030 0030 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin Acorn Single Dose Caps. Sh.A3.5
22 D83600221 0022 0022 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin Acorn Single Dose Caps. Sh. A1
23 D83600190 0019 0019 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin 2 Acorn Nano Micro Hybrid-Syringe Incisal
24 D83600180 0018 0018 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin 2 Acorn Nano Micro Hybrid-Syringe Shade B1
25 D83600150 0015 0015 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin 2 Acorn Nano Micro Hybrid-Syringe Shade D3
26 D83600120 0012 0012 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin 2 Acorn Nano Micro Hybrid-Syringe Shade A4
27 D83600060 0006 0006 Pearl is a self-cured, filled permanent cement designed for cementing convention Pearl is a self-cured, filled permanent cement designed for cementing conventional cast restorations on most vital and non-vital teeth. It also cements bonded bridges of both cast and etched (Maryland) and perforated base (Rochette) types. It is also suitable for cementing prefabricated laminate veneers, ceramic crowns, inlays, onlays, pins, posts and periodontal splinting.• Versatile.• Predictable, controllable and reproducible working time.• Excellent biological and chemical resistance to oral environment.• Excellent adhesion to both the tooth and metal surfaces.• High compressive and diametral tensile strength.• Simplicity in application. EMA Cement, Dental 2 Pearl Composite Luting Cement Syringe System, Part B Single Syringe
28 D83600441 0044 0044 • Eagle-Light, Self & Dual-Cure Core Build-Up Material In dual cure mode restor • Eagle-Light, Self & Dual-Cure Core Build-Up Material In dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light.• Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode.• Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts.• Moldable, non-sticky consistency.• Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure.• Contains moderately hard filler for easier carving and shaping.• Does not require refrigeration: long shelf life at ambient temperatures.• The Standard Eagle kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics. EBF Material, Tooth Shade, Resin Eagle Part A Cont. (Two 4.5 g Syringes)
29 D83600431 0043 0043 • Eagle-Light, Self & Dual-Cure Core Build-Up Material In dual cure mode restor • Eagle-Light, Self & Dual-Cure Core Build-Up Material In dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light.• Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode.• Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts.• Moldable, non-sticky consistency.• Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure.• Contains moderately hard filler for easier carving and shaping.• Does not require refrigeration: long shelf life at ambient temperatures.• The Standard Eagle kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics. EBF Material, Tooth Shade, Resin Eagle Part A Nat (Two 4.5 g Syringes)
30 D83600540 0054 0054 Etch Gel-available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% p Etch Gel-available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. • Convenient dispensing system with disposable tips• Easy to wash off• Economical• Colored for precise application• Excellent wetting characteristics• Non-drying• Direct to tooth application with disposable luer-lock tips• Refillable applicator syringes EBF Material, Tooth Shade, Resin 2 Dental Etchant (Enamel Conditioner), 1kg Bottle
31 D83600640 0064 0064 Orion in the chemical cure form is a paste/paste system. The dentist has a choic Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns. EBF Material, Tooth Shade, Resin 2 Orion-L/C Core Build-Up Material Natural, Single Syringe
32 D83600600 0060 0060 • Skyrock M is a paste/liquid system.• Well-balanced x-ray opacity permits easy • Skyrock M is a paste/liquid system.• Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts.• It is moldable and non-sticky yet has an adhesive consistency.• Allows one to control consistency, wherever desirable, by adding more or less liquid.• Contains moderately hard filler for easier carving and shaping.• Does not require refrigeration: long shelf life at ambient temperatures.• Standard Skyrock M kit comes in two shades: one is contrasting, for easy distinguishing from tooth structure; the other is natural, for use under semi-transparent ceramics. EBF Material, Tooth Shade, Resin 2 Skyrock M P/L Core Build Up Material Part B Liquid, Bottle
33 D83600550 0055 0055 Fantastic-M orthodontic adhesive is designed to set on contact, “Cure-On Touch”, Fantastic-M orthodontic adhesive is designed to set on contact, “Cure-On Touch”, thus saving the dentist chair time. This procedure can also minimize erratic mixing procedures, and therefore https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930708#reducing the possibility of errors caused by paste inconsistencies, a problem often encountered in other types of adhesives. Fantastic M has strong, reliable bond, mistake-proof cure-on-touch system: fast and easy to use, color stable and it economical in application. Fantastic-M starts to set only after the bracket is applied to the tooth, giving the operator the convenience and security of virtually unlimited working time. This material is very reliable due to its outstanding adhesive properties. Also, due to the soft filler, Fantastic-M is easy to clean. The material is highly tacky, therefore, brackets will not slide after being placed on the tooth, but rather they will remain immobilized until the material cures. Delayed cure time permits the operator to correct the position of the brackets up to 15 seconds after placement. Fantastic-M is very economical, unlike conventional adhesives that are normally mixed in excess. DYH Adhesive, Bracket And Tooth Conditioner, Resin 2 Fantastic-M Contact Cure Orthodontic Adhesive, Activator, Bottle
34 D83600461 0046 0046 Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula)• in dual c Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula)• in dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light.• Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode.• Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts.• Moldable, non sticky consistency.• Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure.• Contains moderately hard filler for easier carving and shaping.• Does not require refrigeration: long shelf life at ambient temperatures.• The Standard Saturn M kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics. EBF Material, Tooth Shade, Resin Saturn M Rest Paste Natural (Two 5 g syringes)
35 D83600370 0037 0037 L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite)L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance.OUTSTANDING FEATURES OF THE MATERIALHigh adhesive strength to etched enamel without the use of bonding agents.Superior aesthetics due to well balanced opacity and light reflectance.Excellent color stability.Reduced oxygen inhibited layer contributes to the ease of finishing.Does not require refrigeration. Shelf life in excess of two years.Fast in application–one component restorative system.Excellent flow of the material facilitates application.May be cured with any dentalcuring instrument operating in the visible range. EBF Material, Tooth Shade, Resin 2 L-SHA-Flowable Composite Syr. Incisal
36 D83600340 0034 0034 L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite)L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance.OUTSTANDING FEATURES OF THE MATERIALHigh adhesive strength to etched enamel without the use of bonding agents.Superior aesthetics due to well balanced opacity and light reflectance.Excellent color stability.Reduced oxygen inhibited layer contributes to the ease of finishing.Does not require refrigeration. Shelf life in excess of two years.Fast in application–one component restorative system.Excellent flow of the material facilitates application.May be cured with any dentalcuring instrument operating in the visible range. EBF Material, Tooth Shade, Resin 2 L-SHA-Flowable Composite Syr. Shade A1
37 D83600130 0013 0013 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin 2 Acorn Nano Micro Hybrid-Syringe Shade B3
38 D83610091 1009 1009 • Eagle-Light, Self & Dual-Cure Core Build-Up Material In dual cure mode restor • Eagle-Light, Self & Dual-Cure Core Build-Up Material In dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light.• Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode.• Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts.• Moldable, non-sticky consistency.• Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure.• Contains moderately hard filler for easier carving and shaping.• Does not require refrigeration: long shelf life at ambient temperatures.• The Standard Eagle kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics. EBF Material, Tooth Shade, Resin 2 Eagle-Light, Self & Dual-Cure Core Build-Up Material
39 D83600500 0050 0050 • Simple and fast application technique• Compatible with all light-cured restora • Simple and fast application technique• Compatible with all light-cured restorative materials and cements• Long shelf-life with no need for refrigeration• Economical• No pulp irritation KLE Agent, Tooth Bonding, Resin 2 Bonding Agent Visible Light Cure
40 D83600390 0039 0039 L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite)L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance.OUTSTANDING FEATURES OF THE MATERIALHigh adhesive strength to etched enamel without the use of bonding agents.Superior aesthetics due to well balanced opacity and light reflectance.Excellent color stability.Reduced oxygen inhibited layer contributes to the ease of finishing.Does not require refrigeration. Shelf life in excess of two years.Fast in application–one component restorative system.Excellent flow of the material facilitates application.May be cured with any dentalcuring instrument operating in the visible range. EBF Material, Tooth Shade, Resin 2 L-SHA-Flowable Composite Syr. Sh. C1
41 D83600311 0031 0031 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin Acorn Single Dose Caps. Sh. C3
42 D83600281 0028 0028 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin Acorn Single Dose Caps. Sh. C2
43 D83600251 0025 0025 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin Acorn Single Dose Caps. Sh. B2
44 D83600231 0023 0023 Acorn composite suitable for: Class III, IV, V, as well as, class I and II resto Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers.A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations. EBF Material, Tooth Shade, Resin Acorn Single Dose Caps. Sh. A2
45 D83600210 0021 0021 Dent Zar’s Z-Bond is a One-Step Light-Cured Self-Etching Dentin/Enamel Bonding A Dent Zar’s Z-Bond is a One-Step Light-Cured Self-Etching Dentin/Enamel Bonding Adhesive, which releases fluorides and does not require mixing, because the adhesive combines properties of etching and bonding in a single bottle. The result is fast and saves chair time. Z-Bond markedly reduces sensitivity due to the fact that the adhesive penetrates the smear layer and adheres to the tooth structure without opening tubules. The work effort is significantly reduced and simplified with Z Bond. All adhesive treatment steps are included in one component. Z Bond is a 7th generation of bonding dentin/enamel adhesives. Z Bond is designed to promote adhesion to tooth structure in the following applications: KLE Agent, Tooth Bonding, Resin 2 Z Bond-Visible Light Cure One-Step Bonding Adhesive
46 D83600050 0005 0005 Pearl is a self-cured, filled permanent cement designed for cementing convention Pearl is a self-cured, filled permanent cement designed for cementing conventional cast restorations on most vital and non-vital teeth. It also cements bonded bridges of both cast and etched (Maryland) and perforated base (Rochette) types. It is also suitable for cementing prefabricated laminate veneers, ceramic crowns, inlays, onlays, pins, posts and periodontal splinting.• Versatile.• Predictable, controllable and reproducible working time.• Excellent biological and chemical resistance to oral environment.• Excellent adhesion to both the tooth and metal surfaces.• High compressive and diametral tensile strength.• Simplicity in application. EMA Cement, Dental 2 Pearl Composite Luting Cement Syringe System, Part A Single Syringe
47 D83600040 0004 0004 Pearl is a self-cured, filled permanent cement designed for cementing convention Pearl is a self-cured, filled permanent cement designed for cementing conventional cast restorations on most vital and non-vital teeth. It also cements bonded bridges of both cast and etched (Maryland) and perforated base (Rochette) types. It is also suitable for cementing prefabricated laminate veneers, ceramic crowns, inlays, onlays, pins, posts and periodontal splinting.• Auto-mix system.• Versatile.• Predictable, controllable and reproducible working time.• Excellent biological and chemical resistance to oral environment.• Excellent adhesion to both the tooth and metal surfaces.• High compressive and diametral tensile strength.• Simplicity in application. EMA Cement, Dental 2 Pearl Composite Luting Cement Auto-Mix System, Single Carthridge
48 D83610161 1016 1016 Orion in the chemical cure form is a paste/paste system. The dentist has a choic Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the light-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns. EBF Material, Tooth Shade, Resin 2 Orion-Chemical and L/C Core Build-Up Material
49 D83600630 0063 0063 Orion in the chemical cure form is a paste/paste system. The dentist has a choic Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns. EBF Material, Tooth Shade, Resin 2 Orion-Chemical and L/C Core Build-Up Material Part B, Jar
50 D83600620 0062 0062 Orion in the chemical cure form is a paste/paste system. The dentist has a choic Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns. EBF Material, Tooth Shade, Resin 2 Orion-Chemical and L/C Core Build-Up Material Part A Contrast, Jar
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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14 E217284701 28470 28470 Visalys Veneer Starter Set Visalys Veneer KETTENBACH GMBH & CO. KG
15 E217284561 28456 28456 Visalys Veneer Composite Mix Visalys Veneer KETTENBACH GMBH & CO. KG
16 E217284551 28455 28455 Visalys Veneer Composite Enamel Visalys Veneer KETTENBACH GMBH & CO. KG
17 E217284541 28454 28454 Visalys Veneer Composite A3.5 Visalys Veneer KETTENBACH GMBH & CO. KG
18 E217284531 28453 28453 Visalys Veneer Composite A3 Visalys Veneer KETTENBACH GMBH & CO. KG
19 E217284521 28452 28452 Visalys Veneer Composite A2 Visalys Veneer KETTENBACH GMBH & CO. KG
20 E217284511 28451 28451 Visalys Veneer Composite A1 Visalys Veneer KETTENBACH GMBH & CO. KG
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22 E21728445S1 28445S 28445S Visalys Veneer Size S, Lower/UK 45/US29 Visalys Veneer KETTENBACH GMBH & CO. KG
23 E21728445M1 28445M 28445M Visalys Veneer Size M, Lower/UK 45/US29 Visalys Veneer KETTENBACH GMBH & CO. KG
24 E21728444S1 28444S 28444S Visalys Veneer Size S, Lower/UK 44/US28 Visalys Veneer KETTENBACH GMBH & CO. KG
25 E21728444M1 28444M 28444M Visalys Veneer Size M, Lower/UK 44/US28 Visalys Veneer KETTENBACH GMBH & CO. KG
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27 E21728443M1 28443M 28443M Visalys Veneer Size M, Lower/UK 43/US27 Visalys Veneer KETTENBACH GMBH & CO. KG
28 E21728442S1 28442S 28442S Visalys Veneer Size S, Lower/UK 42/US26 Visalys Veneer KETTENBACH GMBH & CO. KG
29 E21728442M1 28442M 28442M Visalys Veneer Size M, Lower/UK 42/US26 Visalys Veneer KETTENBACH GMBH & CO. KG
30 E21728441S1 28441S 28441S Visalys Veneer Size S, Lower/UK 41/US25 Visalys Veneer KETTENBACH GMBH & CO. KG
31 E21728441M1 28441M 28441M Visalys Veneer Size M, Lower/UK 41/US25 Visalys Veneer KETTENBACH GMBH & CO. KG
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