BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACE BASIC DENTAL IMPLANT PACK II

    K Number: K922649 · Decision Jan 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    21
    Review Days
    586

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    Basic Information

    Device Name
    ACE BASIC DENTAL IMPLANT PACK II
    K Number
    K922649
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ace Surgical Supply Co., Inc.
    Date Received
    June 3, 1992
    Decision Date
    January 10, 1994
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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