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510(k) Data Aggregation

    K Number
    K250804
    Device 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
    872.3310
    Why 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
    K240735
    Device 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
    872.3310
    Why 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
    K223365
    Device Name
    RODIN Palette Naturalizing Kit
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2023-03-27

    (144 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why 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
    K211854
    Device Name
    VITA Akzent LC
    Manufacturer
    VITA Zahnfabrik GmbH H Rauter & Co
    Date Cleared
    2021-11-22

    (159 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why 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
    K162408
    Device Name
    Nano Varnish, Plaquit, Lightpaint on Surface
    Manufacturer
    DREVE DENTAMID GMBH
    Date Cleared
    2018-04-05

    (584 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why 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
    K163568
    Device Name
    SHOFU RESIN GLAZE
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2017-08-16

    (240 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why 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
    K133836
    Device Name
    OPTIGLAZE COLOR
    Manufacturer
    GC AMERICA INC.
    Date Cleared
    2014-03-06

    (78 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why 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
    K123761
    Device Name
    VITA ENAMIC STAINS
    Manufacturer
    INNOVATION MEDITECH GMBH
    Date Cleared
    2013-03-01

    (84 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why 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
    K093019
    Device Name
    ENAMELITE ACRYSEAL SPRAY SEALANT
    Manufacturer
    ENAMELITE LLC
    Date Cleared
    2009-12-22

    (84 days)

    Product Code
    EBD, EBI
    Regulation Number
    872.3310
    Why 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
    K082285
    Device Name
    EASY GLAZE
    Manufacturer
    VOCO GMBH
    Date Cleared
    2008-10-24

    (74 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why 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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