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Found 20 results
510(k) Data Aggregation
K Number
K222435Device Name
Renamel® Microhybrid ;Renamel® Flowable Microhybrid
Manufacturer
Date Cleared
2022-10-11
(60 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Cosmedent, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Renamel Microhybrid
- · Anterior restorations (Class III and IV)
- · Deep Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- · Restorations in the posterior region (Class I and II)
- · Veneering of discolored teeth
- · Closing of diastemas by vestibular veneering
- · Repair of composite and ceramic veneers
Renamel Flowable Microhybrid
- · Class V restorations
- · Sealing margins
- · Repairing pitted areas in hybrid restorations
- · Small occlusal and lingual repairs
- · In deep Class V restorations to block out shine through prior to overlay with Renamel Microfill or Renamel Microhybrid
Device Description
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K Number
K211259Device Name
Renamel Bulkfill
Manufacturer
Date Cleared
2021-06-24
(59 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Cosmedent, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1. Direct Posterior Restorations (including occlusal surfaces)
2. Replacement of individual cusps
3. Base-liner under direct restorations.
4. Restorations of deciduous teeth
5. Class V restorations (cervical caries, root erosion, wedge-shaped defects)
Device Description
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K Number
K172707Device Name
Renamel Microfill
Manufacturer
Date Cleared
2017-12-05
(88 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Cosmedent, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Renamel® Microfill is intended to be used to create lifelike dental restoration.
Indications for Use:
Renamel® Microfill is designed for,
- Direct anterior veneers
- Anterior Class III and IV restorations
- Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- Closing of diastemas
- Repair of composite and ceramic veneers
- Top layer of Class I and II restorations
Device Description
Renamel® Microfill is light-cured, microfilled, highly polishable dental restorative material. According to the applicable FDA recognized consensus standard ISO 4049 - "Dentistry -Polymer-based restorative materials", this device is classified as Type 1, Class 2, Group 1: Polymer-based restorative materials, involving occlusal surfaces, which uses external energy source for intra-orally curing. Renamel® Microfill consists of multi-functional acrylic Resin and fillers of 0.04 - 0.2 micron sized particles of inorganic and prepolymerized composite (70% by weight, 60% by volume). These devices possess physical and mechanical properties that allow them to function in the oral cavity with esthetic quality that mimics natural enamel surface.
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K Number
K163480Device Name
Renamel NANO +plus
Manufacturer
Date Cleared
2017-02-24
(74 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Cosmedent, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Renamel® NANO™ +plus is designed for,
- Class I-V dental restorations ●
- Direct veneering of anterior teeth
- Splinting
- Repair of composite or ceramic restorations ●
Device Description
Renamel® NANO™ +plus is a light-cure composite resin fabricated from multifunctional 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
K092730Device Name
COSMEDENT BRUSHABLE COMPOSITE
Manufacturer
Date Cleared
2009-11-20
(77 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Date Cleared
2007-04-16
(46 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Date Cleared
2006-05-16
(46 days)
Product Code
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Date Cleared
2005-12-16
(119 days)
Product Code
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Date Cleared
2005-10-21
(38 days)
Product Code
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Date Cleared
2004-12-01
(50 days)
Product Code
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
COSMEDENT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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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