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Found 16 results
510(k) Data Aggregation
K Number
K092730Device Name
COSMEDENT BRUSHABLE COMPOSITE
Manufacturer
COSMEDENT, INC.
Date Cleared
2009-11-20
(77 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.
Device Description
The applicant device is a Brushable Dental Composite, classified as a Tooth Shade Resin Material. It is a low viscosity microfilled composite with a filler percentage of 36%. It is supplied as preloaded, plastic syringes. The material is extruded onto a suitable pad or well and applied to the instrument.
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K Number
K070583Device Name
NANO COMPOSITE
Manufacturer
COSMEDENT, INC.
Date Cleared
2007-04-16
(46 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and repair of composite or ceramic restorations.
Device Description
Cosmedent NANO COMPOSITE is a light-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.
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K Number
K060881Device Name
TEMPORARY CROWN & BRIDGE RESIN
Manufacturer
COSMEDENT, INC.
Date Cleared
2006-05-16
(46 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.
Device Description
Cosmedent TEMPORARY CROWN AND BRIDGE RESIN is a self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials have sufficient physical properties to function in the oral cavity for up to 90 days and have esthetic qualities that mimic natural tooth appearance.
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K Number
K052263Device Name
MULTIPLE (TOOTH DESENSITIZER)
Manufacturer
COSMEDENT, INC.
Date Cleared
2005-12-16
(119 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is used either by a dental professional in the dental office or by a patient at home to treat dentin sensitivity.
Device Description
Cosmedent TOOTH DESENSITIZER is a 3% potassium nitrate and 1200 ppm fluoride ion gel desensitizer. The indication for this product is tooth discomfort caused by dentine sensitivity. TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules. TOOTH DESENSITIZER is available as a clear, green-colored, gel. It can be used either by gently brushing the affected area with the product or it can be used in a custom tray.
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K Number
K052501Device Name
MULTIPLE RESIN TOOTH BONDING AGENT
Manufacturer
COSMEDENT, INC.
Date Cleared
2005-10-21
(38 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Resin Tooth Bonding Agent is used to facilitate the adhesive bonding of restorative/preventive dental materials to dental hard tissues as well as to other restorative materials.
Device Description
Cosmedent Resin Tooth Bonding Agent is a dual-cure 4th generation resin tooth bonding agent based on an acetone solution of room temperature polymerizing dimethacrylates. The device consists of two bottles designated as Primer A and Primer B. Primer A can be used alone and light cured, or it can be mixed with Primer B whereupon the adhesive will self cure in a clinically appropriate amount of time. In either case, two coats of the adhesive are applied to the prepared teeth. The adhesive bond strength of the device is approximately 25 MPa. The product is intended to be used to promote the adhesion of resin composite restoratives to dentin and enamel.
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K Number
K042823Device Name
COSMEDENT PIT & FISSURE SEALANT
Manufacturer
COSMEDENT, INC.
Date Cleared
2004-12-01
(50 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental pit and fissure sealant.
Device Description
Cosmedent PIT & FISSURE SEALANT is a light-cure, moderately filled, resin based dental sealant. The product will cure or harden upon application of visible light at a wavelength of approximately 465 nanometers at an energy of at least 350 milliwatts. PIT & FISSURE SEALANT is a relatively low viscosity polymerizable resin based on bis-GMA, urethane, or similar room temperature curing diacrylate monomers. The product is intended to be applied to the developmental grooves and fissures of teeth to prevent these areas from being damaged by carious organisms. PIT & FISSURE SEALANT is available either as a clear unfilled resin or as a filled resin. The filled resin is white and mimics occlusal tooth color.
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K Number
K041229Device Name
MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)
Manufacturer
COSMEDENT, INC.
Date Cleared
2004-06-17
(38 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
- A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.
Device Description
A-SILICONE is vinyl polymethyl siloxane dental impression material composed of four viscosities or bodies including: putty, heavy body, medium body, and light body. The material is suitable for use in traditional double mix technique, monophase technique, and putty-wash technique as well as unique combinations of techniques.
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K Number
K040994Device Name
COSMEDENT CORE PASTE
Manufacturer
COSMEDENT, INC.
Date Cleared
2004-06-03
(48 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental core buildup material for use with 4th or 5th generation resin adhesive primer/bonding systems.
Device Description
CORE PASTE is a dual-cure, radiopaque, filled, resin based core buildup material. The product will self-cure upon mixing equal parts of base and catalyst pastes. The setting time and resultant properties can be improved by further curing with a visible light dental curing unit. CORE PASTE is a high strength product ideally suited to buildup or replace lost tooth structure and to perform as a foundation restoration or core. It is used to build a damaged tooth to ideal anatomic form before it is prepared for a fixed dental prosthesis such as a crown. CORE PASTE is available in three shades: a blue material which serves to sharply contrast with tooth structure, a white opaque shade with similar clinical effects, and an esthetic A2 shade for optimal optical effects under esthetic translucent crown materials.
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K Number
K030832Device Name
PRIMOSPLINT SYSTEM
Manufacturer
COSMEDENT, INC.
Date Cleared
2003-09-17
(184 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use for: Primosplint System should be used for producing functional therapy and bite splints.
Device Description
Primosplint is a light composite developed for functional therapy bite splints and other applications. It is fabricated outside of the mouth from stone models. It may be polished mechanically or by the use of a glaze.
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K Number
K011239Device Name
GINDA GUARD
Manufacturer
COSMEDENT, INC.
Date Cleared
2002-02-14
(297 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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