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Found 29 results
510(k) Data Aggregation
K Number
K250804Device Name
ID LIGHT CURE SYSTEM
Manufacturer
ID KOREA CO., LTD.
Date Cleared
2025-06-04
(79 days)
Product Code
EBD, EBF, EBI, KMY, MQC
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Crown, Bridges, Veneer, Onlay & Inlay, Denture, partial denture, Orthodontic appliance, Splints.
- Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
- For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.
Device Description
ID LIGHT CURE SYSTEM is a light-curing resin-based coating material for dental use. It is designed to form a film on the resin surface of dental restorations and prosthetic appliances to enhance smoothness and wear resistance. The material is available in 51 shades.
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K Number
K240735Device Name
visio.lign color, visio.lign shield
Manufacturer
Bredent GmbH & Co. KG
Date Cleared
2024-12-12
(269 days)
Product Code
EBD, EBI, ELM
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
visio.lign color: Characterization with colour effects on the surface of composite restorations, denture base materials and artificial denture teeth.
visio.lign shield: Surface coating and wear resistance of composite restorations, denture base materials and artificial denture teeth.
Device Description
visio.lign shield & color is a light-curing, transparent or coloured, acrylate-based glossy coating.
visio.lign color achieves colour effects on the surface of composite restorations, denture base materials and artificial denture teeth.
visio.lign color is available in 17 shades.
visio.lign shield provides a surface coating on composite restorations, denture base materials and artificial denture teeth. visio.lign shield is available in the thin-bodied version visio.lign shield LV and in the higher-viscosity version visio.lign shield HV.
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K Number
K223365Device Name
RODIN Palette Naturalizing Kit
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2023-03-27
(144 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Characterization of provisionals.
Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
Characterization of C&B composite resin restorations or acrylic resin.
Device Description
Not Found
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K Number
K211854Device Name
VITA Akzent LC
Manufacturer
VITA Zahnfabrik GmbH H Rauter & Co
Date Cleared
2021-11-22
(159 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VITA AKZENT LC Indication range:
- Restorations made of hybrid ceramic
- · Restorations made of light-curing veneering material
- · Restorations made of CAD/CAM composites
- · Prefabricated Teeth
- · Denture bases
Device Description
VITA AKZENT LC is a light-curing methacrylatebased stain/ glaze system for extraoral surface characterization of dental restorations made of hybrid ceramic, resin veneering materials, CAD/CAM composites, prefabricated teeth and denture base resins. It can also be used for internal characterization with the layering technique of veneering composites.
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K Number
K162408Device Name
Nano Varnish, Plaquit, Lightpaint on Surface
Manufacturer
DREVE DENTAMID GMBH
Date Cleared
2018-04-05
(584 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Varnish for final coating for resin temporaries to produce a smooth and shiny surface.
Device Description
The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.
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K Number
K163568Device Name
SHOFU RESIN GLAZE
Manufacturer
Shofu Dental Corporation
Date Cleared
2017-08-16
(240 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SHOFU RESIN GLAZE is indicated to temporarily glaze the following restoration surfaces:
- Artificial resin teeth
- Acrylic denture base materials
- CAD/CAM PMMA materials
- CAD/CAM hybrid ceramic materials
- Indirect composite resins
- Provisional materials
Device Description
Not Found
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K Number
K133836Device Name
OPTIGLAZE COLOR
Manufacturer
GC AMERICA INC.
Date Cleared
2014-03-06
(78 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. For characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth.
2. For obtaining surface smoothness and wear resistance of restorations made of composite. resin, acrylic denture base and artificial acrylic teeth.
Device Description
Optiglaze Color is a light-cured glazing and for characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth, and also for obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth. The material is available in 17 shades.
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K Number
K123761Device Name
VITA ENAMIC STAINS
Manufacturer
INNOVATION MEDITECH GMBH
Date Cleared
2013-03-01
(84 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vita Enamic® Stains are indicated for shade customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials.
Device Description
The Vita Enamic 6 Stains are color Intensive resins used for shade characterization of the The Vita Enamic restorations made from Vita Enamic The shades are supplied in sonder form. This powder is mixed with a liquid and applied in a very thin layer to an Enamic restoration to adjust the shade or create characteristics found in natural teeth, such as cracks, restoration to of the painted restoration is then sealed with a dear light-curing allaze to create a smooth and glossy finish that is resistant to abrasion. The Stains are a dual curing create a sinopon one phymenzation that is prepared outside the mouth.
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K Number
K093019Device Name
ENAMELITE ACRYSEAL SPRAY SEALANT
Manufacturer
ENAMELITE LLC
Date Cleared
2009-12-22
(84 days)
Product Code
EBD, EBI
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enamelite Acryseal and Enamelite Acryseal-CB Spray Sealant is intended for use as a sealant/bonding agent intended to reline, repair, or rebase denture surfaces and CAD/CAM produced/milled acrylic and composite replacement dental restorations.
Device Description
Enamelite Acryseal Spray Sealant is a dental sealant or bonding agent which is packaged for aerosol dispensing. The product is formulated as either an acrylic spray sealer or composite spray sealer. The base product is identical to brush on sealants that have been used for over 40 years in the dental profession. The spray on sealant and bonding agent produces the same finished material surface as commonly used brush-on sealants. Enamelite Acryseal Spray sealing and bonding agent produces a much smoother coating compared to a brush-on method and was designed to replace the outdated brush application of sealing/bonding lacquer.
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K Number
K082285Device Name
EASY GLAZE
Manufacturer
VOCO GMBH
Date Cleared
2008-10-24
(74 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Product Code :
EBD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EASY GLAZE is intended for the following applications:
1. Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
2. Sealing the adhesive interfaces between restoration and tooth structure.
3. Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
4. Sealing glass ionomer cement liners/build-up restorations before taking impressions.
Device Description
EASY GLAZE is a nanofilled, light-curing coating with natural fluorescence for sealing surfaces. The coated surface is luminous, provides protection against discolouration and yields a natural appearance. EASY GLAZE can be polymerised with all light-curing dental devices.
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