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510(k) Data Aggregation

    K Number
    K081017
    Device Name
    TEMPLATE AND COUNTER-FIT
    Manufacturer
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
    Date Cleared
    2008-08-04

    (117 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TEMPLATE AND COUNTER-FIT

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

    Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental impression material. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The letter acknowledges that the device (Template and CounterFit) is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. However, it does not detail any performance studies, test results, ground truth establishment, or sample sizes related to the device's technical specifications.

    Therefore, I cannot provide the requested information based on the provided text.

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