LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K950260
    Device Name
    QUICK COUPLING DEVICE FOR DENTAL PROSTHESES
    Manufacturer
    DR. JOSEPH E. GRASSO, D.D.S.
    Date Cleared
    1997-09-09

    (960 days)

    Product Code
    DZE,FEB
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUICK COUPLING DEVICE FOR DENTAL PROSTHESES

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

    Not Found

    Device Description

    Quick Coupling For Dental Prostheses

    AI/ML Overview

    This letter is a 510(k) clearance letter from the FDA, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance, study design, or ground truth establishment.

    To answer your questions, I would need to analyze a different document, specifically a study report or a 510(k) submission that details the clinical or performance testing conducted for the "Quick Coupling For Dental Prostheses."

    This letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not provide any performance data or study details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1