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

    TOMAS PIN SD 6, 8, AND 10 MM

    K Number: K062733 · Decision Nov 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    51
    Applicant Total
    7
    Review Days
    57

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    Basic Information

    Device Name
    TOMAS PIN SD 6, 8, AND 10 MM
    K Number
    K062733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentaurum
    Date Received
    September 13, 2006
    Decision Date
    November 9, 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 Dentaurum

    K Number Device Name
    K062732 TOMAS PIN 6 MM
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    K030980 DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
    K030977 DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
    K030641 CONTEC LIGHT