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

    P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)

    K Number: K070478 · Decision Sep 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    4
    Review Days
    212

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    Basic Information

    Device Name
    P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)
    K Number
    K070478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Straumann Manufacturing, Inc.
    Date Received
    February 20, 2007
    Decision Date
    September 20, 2007
    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 Straumann Manufacturing, Inc.

    K Number Device Name
    K092814 STRAUMANN DENTAL ABUTMENTS
    K090260 MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
    K080239 P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS