BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM

    K Number: K013383 · Decision Jan 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
    K Number
    K013383
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomedical Implant Technology, Inc.
    Date Received
    October 12, 2001
    Decision Date
    January 10, 2002
    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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