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

    MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS

    K Number: K052648 · Decision Oct 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    51
    Review Days
    24

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    Basic Information

    Device Name
    MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
    K Number
    K052648
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Implant Innovations, Inc.
    Date Received
    September 26, 2005
    Decision Date
    October 20, 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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    Other Clearances by Implant Innovations, Inc.

    K Number Device Name
    K062636 OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS
    K063341 3I OSSEOTITE CERTAIN DENTAL IMPLANTS
    K063286 OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE
    K063403 CONICAL ANGLED ABUTMENT
    K061629 CERTAIN PREVAIL DENTAL IMPLANT
    K062432 NANOTITE DENTAL IMPLANTS
    K061969 PREFORMANCE POSTS AND TEMPORARY CYLINDERS
    K061177 PROVIDE TEMPORARY CYLINDER
    K060291 PREFORMANCE TEMPORARY CYLINDER
    K053170 PREFORMANCE POSTS
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