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510(k) Data Aggregation

    K Number
    K253248

    Validate with FDA (Live)

    Device Name
    Bright Cavity Liner
    Manufacturer
    Dmp Dental Industry S.A.
    Date Cleared
    2026-01-13

    (106 days)

    Product Code
    EJK
    Regulation Number
    872.3250
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    • Lining the floor and walls of the cavity prior to application of filling materials

    Device Description

    Not Found

    AI/ML Overview

    N/A

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