LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K072213
    Device Name
    PERIMETRICS PERIOMETER
    Manufacturer
    PERIMETRICS, INC.
    Date Cleared
    2008-08-29

    (386 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PERIMETRICS PERIOMETER

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

    The Periometer is a unit that precisely measures the damping characteristics of the periodonium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but without access to the full 510(k) submission document for K072213, I cannot provide details on the acceptance criteria, device performance, or study specifics for the Periometer device. The provided text is only the FDA's decision letter and the Indications for Use statement, which does not contain the detailed technical data and study information required to answer your questions.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1