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

    OMNI-TIGHT

    K Number: K082749 · Decision Dec 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    6
    Review Days
    76

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    Basic Information

    Device Name
    OMNI-TIGHT
    K Number
    K082749
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Basic Dental Implant Systems, Inc.
    Date Received
    September 19, 2008
    Decision Date
    December 4, 2008
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Basic Dental Implant Systems, Inc.

    K Number Device Name
    K072595 OMNI-TIGHT
    K022912 POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM
    K013682 MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM
    K012299 MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
    K001259 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM