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

    OSSEOTITE II MODEL XIFOSSXXX

    K Number: K100724 · Decision Apr 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    13
    Review Days
    382

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    Basic Information

    Device Name
    OSSEOTITE II MODEL XIFOSSXXX
    K Number
    K100724
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet 3i, Inc.
    Date Received
    March 15, 2010
    Decision Date
    April 1, 2011
    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 Biomet 3i, Inc.

    K Number Device Name
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    K101607 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS
    K101608 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS
    K102209 ENCODE PATIENT SPECIFIC ABUTMENT
    K101582 CAM STRUCTSURE BARS
    K092341 LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION
    K080864 CAM STRUCTSURE PRECISION MILLED BARS
    K073345 CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT
    K072363 NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
    Search all 13 clearances from Biomet 3i, Inc. →