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