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

    ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M

    K Number: K061397 · Decision Aug 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    51
    Applicant Total
    21
    Review Days
    89

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    Basic Information

    Device Name
    ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
    K Number
    K061397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ace Surgical Supply Co., Inc.
    Date Received
    May 19, 2006
    Decision Date
    August 16, 2006
    Product Code
    OAT
    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
    OAT Implant, Endosseous, Orthodontic

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    Other Clearances by Ace Surgical Supply Co., Inc.

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