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

    ZYGOMA TIUNITE

    K Number: K050641 · Decision Apr 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    9
    Review Days
    24

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    Basic Information

    Device Name
    ZYGOMA TIUNITE
    K Number
    K050641
    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
    March 14, 2005
    Decision Date
    April 7, 2005
    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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    K062566 NOBELREPLACE TAPERED CONICAL CONNECTION
    K052885 ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315
    K043312 NOBELRONDO DENTAL CERAMIC - ZIRCONIA