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

    NOBELREPLACE HEXAGONAL IMPLANT

    K Number: K073142 · Decision Jan 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    9
    Review Days
    65

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    Basic Information

    Device Name
    NOBELREPLACE HEXAGONAL IMPLANT
    K Number
    K073142
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nobel Biocare USA, LLC
    Date Received
    November 7, 2007
    Decision Date
    January 11, 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 Nobel Biocare USA, LLC

    K Number Device Name
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    K132746 NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
    K110171 NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
    K083100 GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
    K062566 NOBELREPLACE TAPERED CONICAL CONNECTION
    K052885 ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315
    K050641 ZYGOMA TIUNITE
    K043312 NOBELRONDO DENTAL CERAMIC - ZIRCONIA