BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS

    K Number: K070533 · Decision Jun 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    15
    Review Days
    115

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    Basic Information

    Device Name
    BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS
    K Number
    K070533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.T.I. Biotechnology Institute, Sl.
    Date Received
    February 26, 2007
    Decision Date
    June 21, 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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