LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053427
    Device Name
    FRESH, DENTAL IMPRESSION MATERIAL
    Manufacturer
    EXACTA DENTAL PRODUCTS, INC.
    Date Cleared
    2006-01-13

    (36 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXACTA DENTAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fresh, Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
    Device Description
    The Fresh, Dental Impression Material is described as a Class II , impression material that is used to reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant.
    Ask a Question

    Page 1 of 1