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510(k) Data Aggregation

    K Number
    K130125
    Device Name
    MTA CEMENTS
    Manufacturer
    S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN
    Date Cleared
    2013-07-24

    (188 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MTA-B :
    Repair of root perforations during root canal therapy
    Root-end filings
    Pulp capping
    Repair of root canals as an apical plug during apexification
    MTA-T :
    Repair of root perforations during root canal therapy
    Root-end filings
    Pulp capping
    Repair of root canals as an apical plug during apexification
    MTA-XR:
    Repair of root perforations during root canal therapy
    Root-end filings
    Pulp capping
    Repair of root canals as an apical plug during apexification
    MTA-XR Flow:
    Repair of root perforations during root canal therapy
    Pulp capping
    Repair of root canals as an apical plug during apexification

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for "MTA Cements," outlining its indications for use and regulatory compliance. It does not include details on performance studies, sample sizes, expert qualifications, or ground truth establishment.

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