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510(k) Data Aggregation

    K Number
    K972775
    Device Name
    FASTDAM
    Manufacturer
    INTERDENT, INC.
    Date Cleared
    1998-02-27

    (218 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERDENT, INC.

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

    SOFT TISSUE ISOLATION22 MOISTURE PREVENTION 2

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the "FastDam" device (K972775), a dental product. It does not contain the kind of detailed study information (acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, MRMC studies, or training set details) that your request asks for.

    The letter simply states that the FDA has determined the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and therefore may be marketed. It lists the indications for use as "SOFT TISSUE ISOLATION" and "MOISTURE PREVENTION."

    Without the actual 510(k) submission document, it is impossible to provide the information you've requested. The clearance letter itself does not include the detailed technical and clinical study data.

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