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

    BITEM LOCK, MODELS SW006, SW012

    K Number: K994357 · Decision Mar 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    102
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    BITEM LOCK, MODELS SW006, SW012
    K Number
    K994357
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermoelastic Technologies, Inc.
    Date Received
    December 27, 1999
    Decision Date
    March 14, 2000
    Product Code
    EJF
    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
    EJF Bracket, Metal, Orthodontic

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