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

    NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)

    K Number: K090630 · Decision Jun 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    41
    Applicant Total
    92
    Review Days
    85

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    Basic Information

    Device Name
    NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
    K Number
    K090630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nobel Biocare AB
    Date Received
    March 9, 2009
    Decision Date
    June 2, 2009
    Product Code
    FZE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FZE Prosthesis, Nose, Internal

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