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

    BIOMESH BIODEGRADABLE GTR BARRIER

    K Number: K990363 · Decision Apr 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    BIOMESH BIODEGRADABLE GTR BARRIER
    K Number
    K990363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Samyang Corp.
    Date Received
    February 5, 1999
    Decision Date
    April 9, 1999
    Product Code
    NPK
    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
    NPK Barrier, Synthetic, Intraoral

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