| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | J011294243600 | 294-243-60 | Triceram® dentin D3, 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 2 | J011294242300 | 294-242-30 | Triceram® dentin D2, 15g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 3 | J011294234600 | 294-234-60 | Triceram® dentin C4, 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 4 | J011294234300 | 294-234-30 | Triceram® dentin C4, 15g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 5 | J011294232600 | 294-232-60 | Triceram® dentin C2, 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 6 | J011294232300 | 294-232-30 | Triceram® dentin C2, 15g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 7 | J011294223600 | 294-223-60 | Triceram® dentin B3, 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 8 | J011294213300 | 294-213-30 | Triceram® dentin A3, 15g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 9 | J011294144600 | 294-144-60 | Triceram® opaque dentin D4, 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 10 | J011294143300 | 294-143-30 | Triceram® opaque dentin D3, 15g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 11 | J011294142600 | 294-142-60 | Triceram® opaque dentin D2, 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 12 | J011294142300 | 294-142-30 | Triceram® opaque dentin D2, 15g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 13 | J011294121600 | 294-121-60 | Triceram® opaque dentin B1, 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 14 | J011294114600 | 294-114-60 | Triceram® opaque dentin A3,5; 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 15 | J011294113600 | 294-113-60 | Triceram® opaque dentin A3, 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 16 | J011274298600 | 274-298-60 | CCS dentin CC 53, 40g/ dental ceramic material | EIH | POWDER, PORCELAIN | 2 | N.A. | |
| 17 | J011294112600 | 294-112-60 | Triceram® opaque dentin A2, 40g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 18 | J011294112300 | 294-112-30 | Triceram® opaque dentin A2, 15g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 19 | J011294111300 | 294-111-30 | Triceram® opaque dentin A1, 15g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 20 | J011294257300 | 294-257-30 | Triceram® Chroma dentin 7, 15 g / dental ceramic material | EIH | POWDER, PORCELAIN | 2 | Triceram® | |
| 21 | J011889015000 | 889-015-00 | dentaform® Band, Tooth 37, Size 15 | ECM | BAND, PREFORMED, ORTHODONTIC | dentaform® | ||
| 22 | J011889014000 | 889-014-00 | dentaform® Band, Tooth 37, Size 14 | ECM | BAND, PREFORMED, ORTHODONTIC | dentaform® | ||
| 23 | J011871014000 | 871-014-00 | Standard Band, Tooth 47-46/36-37, Size 14 | ECM | BAND, PREFORMED, ORTHODONTIC | N.A. | ||
| 24 | J011887004000 | 887-004-00 | dentaform® Band, Tooth 27, Size 4 | ECM | BAND, PREFORMED, ORTHODONTIC | dentaform® | ||
| 25 | J011886008000 | 886-008-00 | dentaform® Band, Tooth 17, Size 8 | ECM | BAND, PREFORMED, ORTHODONTIC | dentaform® | ||
| 26 | J011886003000 | 886-003-00 | dentaform® Band, Tooth 17, Size 3 | ECM | BAND, PREFORMED, ORTHODONTIC | dentaform® | ||
| 27 | J011889032000 | 889-032-00 | dentaform® Band, Tooth 37, Size 32 | ECM | BAND, PREFORMED, ORTHODONTIC | dentaform® | ||
| 28 | J011885305180 | 885-305-18 | dentaform® Band, tooth 36, size 5/Roth 18 | ECM | BAND, PREFORMED, ORTHODONTIC | 1 | dentaform® | |
| 29 | J011883004000 | 883-004-00 | dentaform® Band, Tooth 26, Size 4 | ECM | BAND, PREFORMED, ORTHODONTIC | dentaform® | ||
| 30 | J011882307220 | 882-307-22 | dentaform® Band, tooth 16, size 7/Roth 22 | ECM | BAND, PREFORMED, ORTHODONTIC | 1 | dentaform® | |
| 31 | J011871022000 | 871-022-00 | Standard Band, Tooth 47-46/36-37, Size 22 | ECM | BAND, PREFORMED, ORTHODONTIC | N.A. | ||
| 32 | J011871018000 | 871-018-00 | Standard Band, Tooth 47-46/36-37, Size 18 | ECM | BAND, PREFORMED, ORTHODONTIC | N.A. | ||
| 33 | J011880205000 | 880-205-00 | dentaform® Snap Band, Tooth 46, Size 5 | ECM | BAND, PREFORMED, ORTHODONTIC | dentaform® | ||
| 34 | J011879304180 | 879-304-18 | dentaform® Snap Band, tooth 26, size 4/Roth 18 | ECM | BAND, PREFORMED, ORTHODONTIC | 1 | dentaform® | |
| 35 | J011870020000 | 870-020-00 | Standard Band, Tooth 17-16/26-27, Size 20 | ECM | BAND, PREFORMED, ORTHODONTIC | N.A. | ||
| 36 | J011870004000 | 870-004-00 | Standard Band, Tooth 17-16/26-27, Size 4 | ECM | BAND, PREFORMED, ORTHODONTIC | N.A. | ||
| 37 | J011792020000 | 792-020-00 | Mollin Bracket | EJF | BRACKET, METAL, ORTHODONTIC | N.A. | ||
| 38 | J011726210000 | 726-210-00 | Buccal Tubes, 22 right,0°Torque, 0°Offset | DZD | TUBE, ORTHODONTIC | N.A. | ||
| 39 | J011741045000 | 741-045-00 | Face Bow, 1.15 mm, medium, 90 mm, grey | KCR | FACEBOW | 1 | N.A. | |
| 40 | J011607301000 | 607-301-00 | Activator tubes, inner ø 1.30 mm/51 | KCR | FACEBOW | N.A. | ||
| 41 | J011600303300 | 600-303-30 | Expansion screws, Stainless steel, Magnum | DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | N.A. | ||
| 42 | J011718701320 | 718-701-32 | discovery® pearl bracket, - 1° Torque, 0° Angulation for tooth 32, Roth 18 | EJF | BRACKET, METAL, ORTHODONTIC | 1 | discovery® | |
| 43 | J011700512010 | 700-512-01 | dinamique c Bracket, 0°Torque , 0°Angulation for tooth 31 | EJF | BRACKET, METAL, ORTHODONTIC | 1 | N.A. | |
| 44 | J011632103000 | 632-103-00 | Plastic sleeving, ø 1.90 mm | ECI | BAND, ELASTIC, ORTHODONTIC | 1 | N.A. | |
| 45 | J011607136000 | 607-136-00 | SUS² ball retainer clasps | DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | N.A. | ||
| 46 | J011606701300 | 606-701-30 | Mandibular bow screw acc. to Müller, Stainless Steel | DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | N.A. | ||
| 47 | J011600500300 | 600-500-30 | Sectional screws, straight, Stainless steel, Medium | DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | N.A. | ||
| 48 | J011600301300 | 600-301-30 | Expansion screws, Stainless steel, Medium | DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | N.A. | ||
| 49 | J011600320600 | 600-320-60 | Expansion screw, Stainless steel, Mini | DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | N.A. | ||
| 50 | J011161609000 | 161-609-00 | Orthocryl® Disco glitter, gold | KMY | POSITIONER, TOOTH, PREFORMED | 1 | Orthocryl® |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | D9115578880 | 557-888 | Ortho Lite Cure 4 syringe KIT | ORTHOSOURCE | ORTHOSOURCE | |
| 2 | D9115578810 | 557-881 | Ortho Lite Cure Paste 5 gm Syringe | ORTHOSOURCE | ORTHOSOURCE | |
| 3 | D9115578630 | 557-863 | Ortho Lite Cure Sealant 8 gm Bottle | ORTHOSOURCE | ORTHOSOURCE | |
| 4 | D9115578610 | 557-861 | Superbond KIT | ORTHOSOURCE | ORTHOSOURCE | |
| 5 | D9115578460 | 557-846 | Superbond Adhesive 7 gm Syringe | ORTHOSOURCE | ORTHOSOURCE | |
| 6 | D9115576200 | 557-620 | Blue Permaband Composite Light Cure Band Cement 20 gm Syr | ORTHOSOURCE | ORTHOSOURCE | |
| 7 | D9115576070 | 557-607 | Blue Permaband Composite Light Cure Band Cement 7gm Syr | ORTHOSOURCE | ORTHOSOURCE | |
| 8 | D9115574830 | 557-483 | Ultra Permaband 7gm Syringe | ORTHOSOURCE | ORTHOSOURCE | |
| 9 | D9115574790 | 557-479 | Ultra Permaband 20 gm Syringe | ORTHOSOURCE | ORTHOSOURCE | |
| 10 | D9115574750 | 557-475 | Ultra Permaband 6 gm Syringe | ORTHOSOURCE | ORTHOSOURCE | |
| 11 | D9115574420 | 557-442 | Superbond Activator 16 cc | ORTHOSOURCE | ORTHOSOURCE | |
| 12 | D867CLQSPB0 | CLQSPB | CLQSPB | Quick Set Paste is intended for use as an orthodontic bonding adhesive for brack Quick Set Paste is intended for use as an orthodontic bonding adhesive for brackets and appliances. | Quick Set Paste B | XEMAX SURGICAL PRODUCTS INC |
| 13 | D867CLQSPA0 | CLQSPA | CLQSPA | Quick Set Paste is intended for use as an orthodontic bonding adhesive for brack Quick Set Paste is intended for use as an orthodontic bonding adhesive for brackets and appliances. | Quick Set Paste A | XEMAX SURGICAL PRODUCTS INC |
| 14 | D867CLQSP0 | CLQSP | CLQSP | Quick Set Paste is intended for use as an orthodontic bonding adhesive for brack Quick Set Paste is intended for use as an orthodontic bonding adhesive for brackets and appliances. | Quick Set Paste A & B | XEMAX SURGICAL PRODUCTS INC |
| 15 | D867CLABC0 | CLABC | CLABC | Aqua Bond Compostie is a light cure, hydrophilic bracket adhesive, which can be Aqua Bond Compostie is a light cure, hydrophilic bracket adhesive, which can be applied to a dry or slightly contaminated surface. The smooth cohesive past viscosity allows for easy application to any style bracket base, insuring maximum mechanical retention. | Aqua Bond Composite | XEMAX SURGICAL PRODUCTS INC |
| 16 | D83610131 | 1013 | 1013 | 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 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. | Fantastic-M Contact Cure Orthodontic Adhesive | DENT ZAR, INC. |
| 17 | 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. | Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe | DENT ZAR, INC. |
| 18 | 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 | Atlas Dual Cure Cement | DENT ZAR, INC. |
| 19 | 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 | Atlas Dual Cure Cement, Single Carthridge | DENT ZAR, INC. |
| 20 | D83600560 | 0056 | 0056 | 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 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. | Fantastic-M Contact Cure Orthodontic Adhesive, Single Syringe | DENT ZAR, INC. |
| 21 | 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. | Fantastic-M Contact Cure Orthodontic Adhesive, Activator, Bottle | DENT ZAR, INC. |
| 22 | 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. | Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe | DENT ZAR, INC. |
| 23 | D82813309010 | 1330901 | PORCELAIN CONDITIONER | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 24 | D82813306120 | 1330612 | RELY A BOND PASTE 3.5 GM SYRINGE | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 25 | D8281330610 | 1330610 | TRANSBOND LR | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 26 | D8281330606 | 1330606 | TRANSBOND SYRINGE | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 27 | D8281330603 | 1330603 | TRANSBOND XT CAPSULES | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 28 | D82813306000 | 1330600 | LIQUID ETCH LIGHT CURE | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 29 | D82813302700 | 1330270 | SELF CURE PASTE TIPS | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 30 | D82813302270 | 1330227 | SELECT DEFENSE 7ML SEALANT | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 31 | D82813302150 | 1330215 | LIQUID ETCH LARGE 23GM | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 32 | D82813302100 | 1330210 | LIGHT BOND SEALANT WITH FLOURIDE | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 33 | D82813302080 | 1330208 | LIGHT BOND BLUE SYRINGE | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 34 | D82813302070 | 1330207 | LIGHT BOND SYRINGE | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 35 | D8281330206 | 1330206 | SKINNY NOSE LIGHT BOND PASTE TIPS | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 36 | D8281330205 | 1330205 | LIGHT BOND PASTE TIPS | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 37 | D8281330171 | 1330171 | ULTRA BAND LOK CLEAR | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 38 | D8281330121 | 1330121 | FUJI LC BAND AUTOMIX | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 39 | D8281330003 | 1330003 | FUJI SC BAND PASTE PAK | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | ||
| 40 | D81340213100 | 4021310 | 4021310 | PORC LAM POLISH PST SY KIT | Ceri-Prime | DEN-MAT HOLDINGS, LLC |
| 41 | D8134020600 | 402060 | 402060 | PORCELOCK SY KIT | Ceri-Prime | DEN-MAT HOLDINGS, LLC |
| 42 | D813402022B0 | 402022B | 402022B | ETCHANT MD VSC SY 3mL | Other | DEN-MAT HOLDINGS, LLC |
| 43 | D81313990 | 1399 | 1399 | CERI-PRIME 15mL/PORC COND 6g | Ceri-Prime | DEN-MAT HOLDINGS, LLC |
| 44 | D8131398B0 | 1398B | 1398B | CERI-PRIME L/C 5mL | Ceri-Prime | DEN-MAT HOLDINGS, LLC |
| 45 | D81313970 | 1397 | 1397 | CERINATE PRIME L/C 15mL | Cerinate Prime® | DEN-MAT HOLDINGS, LLC |
| 46 | D8131002AB0 | 1002AB | 1002AB | PORC CONDITIONER 6g | Ceri-Prime | DEN-MAT HOLDINGS, LLC |
| 47 | D8130323907000 | 032390700 | 032390700 | REVITALIZE SUPPLEMENTAL KIT | Ceri-Prime | DEN-MAT HOLDINGS, LLC |
| 48 | D8130304025501 | 030402550 | 030402550 | ETCH'N'SEAL RED 8pc SY KIT | Cerinate® | DEN-MAT HOLDINGS, LLC |
| 49 | D8130301255000 | 030125500 | 030125500 | PORCELAIN REPAIR/PFM KIT | Ceri-Prime | DEN-MAT HOLDINGS, LLC |
| 50 | D801SP67028N1 | SP 67-028 N | 67-028 | Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. 30 Part B Carpules, bagged. | SciPharm Cure-On Touch Orthodontic Adhesive | SCIENTIFIC PHARMACEUTICALS, INC. |