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

    OSSEOSPEED TM PROFILE SYSTEM

    K Number: K080156 · Decision Sep 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    10
    Review Days
    238

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    Basic Information

    Device Name
    OSSEOSPEED TM PROFILE SYSTEM
    K Number
    K080156
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Astra Tech AB
    Date Received
    January 23, 2008
    Decision Date
    September 17, 2008
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Astra Tech AB

    K Number Device Name
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    K113424 LOFRIC SINGLE USE URINARY CATHETER
    K111287 ASTRA TECH IMPLANT SYSTEM
    K101005 ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
    K101732 ASTRA TECH IMPLANT SYSTEM
    K091239 ASTRA TECH IMPLANT SYSTEM
    K080396 OSSEOSPEED NARROW
    K072624 ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT