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510(k) Data Aggregation

    K Number
    K253513

    Validate with FDA (Live)

    Device Name
    MultiMatch Flow Chameleon AntiMicrobial Composite
    Manufacturer
    Premier Dental Products Company
    Date Cleared
    2025-11-07

    (1 days)

    Product Code
    EBF,DYH,EBC
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K083051,K201010
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Direct restorations in all cavity classes (I-V)
    • Base / liner under direct restoration
    • Veneering of discolored anterior teeth
    • Splinting of mobile teeth
    • Extended pit and fissure sealing in molars and premolars
    • Repair of composite/ceramic veneers
    • Retention of thermoplastic aligners

    The addition of anti-microbial particles to MultiMatch Flow Chameleon AntiMicrobial Composite reduces demineralization and the total amount of bacteria at the material surface, which is part of the caries-formation process.

    Device Description

    Premier's MultiMatch Flow Chameleon AntiMicrobial Composite is a low viscosity, light-cured, radiopaque, flowable nano-hybrid composite. It is for use in direct Class I-V restorations as a base liner, indirect restorations, and for retention of clear aligners. The restorative has an antimicrobial additive which reduces demineralization and total amount of bacteria at the material surface. The restorative is available in one chameleon shade to fit a variety of tooth-colored shades.

    AI/ML Overview

    N/A

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