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

    NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS

    K Number: K110171 · Decision Jun 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    9
    Review Days
    146

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    Basic Information

    Device Name
    NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
    K Number
    K110171
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nobel Biocare USA, LLC
    Date Received
    January 20, 2011
    Decision Date
    June 15, 2011
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by Nobel Biocare USA, LLC

    K Number Device Name
    K132749 NOBELPROCERA OVERDENTURE BAR
    K132746 NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
    K083100 GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
    K073142 NOBELREPLACE HEXAGONAL IMPLANT
    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