LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K042048
    Device Name
    GELATO PROPHYLAXIS PASTE
    Manufacturer
    DEEPAK PRODUCTS, INC.
    Date Cleared
    2004-10-26

    (88 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEEPAK PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Pastes containing fluoride are not considered a replacement for other forms of fluoride therapy. Gelato dental prophylaxis paste is for professional use only and is designed for application during standard dental practice hygiene procedures. This product contains fluoride at a concentration of 1.23% fluoride ion.
    Device Description
    Gelato Prophylaxis Paste
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1