LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070155
    Device Name
    INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC
    Manufacturer
    OSSEO SCIENTIFIC, LLC
    Date Cleared
    2007-01-25

    (8 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSEO SCIENTIFIC, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INTEGRITY Air Powered Low Speed Handpieces are intended for removing curious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and polishing teeth for use by a trained professional in general dentistry.
    Device Description
    The Integrity Low Speed Handpiece is a 5-vane motor, ranging in speed up to 20,000 RPM, and is compatible to all standard 2, 3 or 4 hole fixed air connection. It accepts all brands of ISO E-Type or U-Type attachments. The Motors and Straight Nose Cone are used for general dentistry procedures.
    Ask a Question

    Page 1 of 1