Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    INNOVATION MEDITECH GMBH

    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.
    Ask a Question

    Page 1 of 1