LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K150454
    Device Name
    Acryfree Denture Base Material and Biosens Denture Base Material
    Manufacturer
    PERFLEX
    Date Cleared
    2015-05-26

    (95 days)

    Product Code
    EBIMQC
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERFLEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    "Acryfree Denture Base Material" and "Biosens Denture Base Material" are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, personal trays, appliances, occlusal splints and night guards.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1