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

    ACETAL DENTAL/PREFORMED CLASP

    K Number: K983558 · Decision Jan 7, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    ACETAL DENTAL/PREFORMED CLASP
    K Number
    K983558
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3285
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dentamax, Inc.
    Date Received
    October 13, 1998
    Decision Date
    January 7, 1999
    Product Code
    EHP
    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
    EHP Clasp, Preformed

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