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

    DURAFLEX

    K Number: K063626 · Decision Feb 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    167
    Registration Numbers
    167
    Same Product Code
    322
    Applicant Total
    2
    Review Days
    64

    Basic Information

    Device Name
    DURAFLEX
    K Number
    K063626
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COSMETIC DENTAL MATERIALS INC
    Date Received
    December 6, 2006
    Decision Date
    February 8, 2007
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

    Similar 510(k) Clearances

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

    Flexible Partial Resin

    FDA 510(k)
    FDA Class 2 ·Dental

    Partial Flex

    FDA 510(k)
    FDA Class 2 ·Dental

    FP3D

    FDA 510(k)
    FDA Class 2 ·Dental

    Apex Flex

    FDA 510(k)
    FDA Class 2 ·Dental

    Asiga DentaBASE

    FDA 510(k)
    FDA Class 2 ·Dental

    Denture Base Resin DT20

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

    Other Clearances by COSMETIC DENTAL MATERIALS INC

    K Number Device Name
    K052040 QUICKSMILE