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510(k) Data Aggregation

    K Number
    K994027
    Device Name
    ACTIVATOR PASTE
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2000-04-13

    (139 days)

    Product Code
    ELW,MAR
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Paste catalyst is used with a condensation-type silicone base paste or putty as a dental impression material to reproduce a patient's teeth and gums, and to provide models for study and for production of restorative prosthetic devices. The paste catalyst causes the base material to set.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth. The document is a 510(k) clearance letter from the FDA for a dental device called "Activator Paste," indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but no performance study details are included.

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