Address:22156 Sherman Way, Unit B,Canoga Park,CA,91303,US
Device Description : 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
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes
Device Description : • 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.
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes
Device Description : • 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.
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes
Device Description : • 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.
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes
Device Description : • 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.
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 789664455
Premarket Exempt : No
Prescription Use : Yes