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

    FRIOS BONESHIELD

    K Number: K973924 · Decision May 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    6
    Review Days
    204

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    Basic Information

    Device Name
    FRIOS BONESHIELD
    K Number
    K973924
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Friatec AG
    Date Received
    October 15, 1997
    Decision Date
    May 7, 1998
    Product Code
    JEY
    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
    JEY Plate, Bone

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    Other Clearances by Friatec AG

    K Number Device Name
    K982576 FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476
    K980630 FRIALIT-2 CORABASE
    K974628 FRIALIT-2 PROTECT ABUTMENT
    K974359 FRIALIT-2 CYLINDER
    K974358 FRIALIT -2 SCREW