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510(k) Data Aggregation

    K Number
    K162654
    Device Name
    mollosil plus
    Manufacturer
    DETAX GmbH & Co.KG
    Date Cleared
    2017-03-13

    (171 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    mollosil plus

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Used for fabricating long-term soft denture relinings by direct or indirect application.

    Device Description

    Not Found

    AI/ML Overview

    This FDA document is a clearance letter for a dental device, "Mollosil Plus," classifying it as substantially equivalent to existing predicate devices. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a performance study report.

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