BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3

    K Number: K030682 · Decision Jun 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    229
    Applicant Total
    4
    Review Days
    114

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
    K Number
    K030682
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioform, Inc.
    Date Received
    March 5, 2003
    Decision Date
    June 27, 2003
    Product Code
    LYC
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYC Bone Grafting Material, Synthetic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LYC), ordered by most recent decision date.

    Bonalive Maxillofacial

    FDA 510(k)
    FDA Class 2 ·Dental

    BONTREE PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    FG Bone Graft M

    FDA 510(k)
    FDA Class 2 ·Dental

    FG Bone Graft B

    FDA 510(k)
    FDA Class 2 ·Dental

    Synthetic Bone Graft Particulate

    FDA 510(k)
    FDA Class 2 ·Dental

    CMFlexTM

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Bioform, Inc.

    K Number Device Name
    K033398 LARYNGEAL AUGMENTATION IMPLANT
    K013243 COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
    K012955 COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER