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510(k) Data Aggregation

    K Number
    K251587

    Validate with FDA (Live)

    Device Name
    VITA VMLC Primer
    Manufacturer
    Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
    Date Cleared
    2026-02-23

    (276 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K974089,K240660
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Adhesive bonding of metal substructure surfaces (non-precious metal alloys, PM alloys, titanium) with (meth-)acrylate-based resins/composites
    • Adhesive bonding of ZrO2 substructure surfaces with (meth-)acrylate-based resins/composites
    • Adhesive bonding of cross-linked composites/resins such as VITA CAD Temp or of high-performance polymers (PEEK, PEKK) with (meth-)acrylate-based resins/composites
    Device Description

    VITA VM LC Primer is a two-component dental bonding system (Primer I and Primer II) used to promote adhesion between dental prosthetic substructures and light-curing (meth)acrylate-based composite veneering resins. Primer I contains functional monomers in a solvent carrier for interaction with substrate surfaces; Primer II is a light-curable methacrylate resin layer that polymerizes using standard dental laboratory light-curing units. The device is supplied as a two-bottle system for sequential application.

    AI/ML Overview

    N/A

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