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

    ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE

    K Number: K051381 · Decision Jul 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    229
    Applicant Total
    21
    Review Days
    49

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    Basic Information

    Device Name
    ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
    K Number
    K051381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ace Surgical Supply Co., Inc.
    Date Received
    May 27, 2005
    Decision Date
    July 15, 2005
    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

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