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510(k) Data Aggregation

    K Number
    K040079
    Device Name
    M.L. PRIMER
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2004-09-09

    (238 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    M.L. Primer is a metal-adhesive primer to promote adhesion between dental metal and dental resin materials intra- or extra-orally.

    M.L. Primer is intended for use for the following:

    • Used when fabricating and repairing resin facing crowns.
    • Used when fabricating and repairing and repairing crowns.
    • Used when repairing porcelain fused to facing crown.
    • Used when fabricating and repairing denture base with metal plate, metal clasp or metal attachments.
    • Used for bonding metal restorations (inlays, onlays, crowns and bridges), metal splints, metal posts on teeth used for their repair.
    • Used for bonding metal restorations (inlays) with adhesive resin cement or used for their repair.
    Device Description

    Not Found

    AI/ML Overview

    There is no information in the provided text about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental product called M.L. Primer, indicating that the device has been found substantially equivalent to a predicate device. It defines the indications for use but does not contain any performance data, study details, or acceptance criteria.

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