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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    **VITA Zahnfabrik GmbH H Rauter **& Co

    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
    K193434
    Device Name
    VITA LUMEX AC
    Manufacturer
    VITA Zahnfabrik GmbH H Rauter & Co
    Date Cleared
    2020-07-21

    (223 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    **VITA Zahnfabrik GmbH H Rauter **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VITA Lumex® AC is used to veneer the following: - Full and partial veneering of zirconia - Full and partial veneering of lithium disilicate - Partial veneering of feldspar ceramic - Reconstruction without a substructure Materials: - Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1) - Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1)
    Device Description
    VITA Lumex® AC is a natural low-fusing veneering ceramic system that is suitable for veneering all ceramic substructures. VITA LUMEX AC standard layering consists of the two Materials DENTINE and ENAMEL. The color-bearing DENTINE materials, which provide good coverage, offer the perfect precondition for the preparation of veneers with intensive shades. With this two-layer alternative, VITA offers an ideal solution for the reproduction of optimal shade results in case of thin walls. Additionally, the intensive shade effect of the DENTINE permits a more generous use of the ENAMEL materials, which create the desired translucency. The user is able to prepare a natural restoration with a lifelike appearance with only two layers. This product is provided non-sterile in glass jars in a powder form to be used in conjunction with the Vita low fusing liquid.
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    K Number
    K193436
    Device Name
    VITA Ambria
    Manufacturer
    VITA Zahnfabrik GmbH H Rauter & Co
    Date Cleared
    2020-05-14

    (155 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    **VITA Zahnfabrik GmbH H Rauter **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrications in the press technique. Indications •Occlusal veneers (table tops), veneers - •Inlays, onlays, partial crowns - ·Crowns in the anterior and posterior areas - ·3-unit anterior bridges up to the second premolar - ·Single tooth restorations as implant suprastructures for anterior and posterior teeth - ·3-unit bridges as implant suprastructures up to the second premolar - · Single tooth mesostructures in the anterior and posterior areas - · Abutment crowns in the anterior and posterior areas
    Device Description
    VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique. VITA Ambria comes in various shades and is packaged in a plastic case of 5 or 3 pc pellets.
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