BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Axiom PX

    K Number: K161177 · Decision Jun 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    6
    Review Days
    415

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    Basic Information

    Device Name
    Axiom PX
    K Number
    K161177
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anthogyr Sas
    Date Received
    April 26, 2016
    Decision Date
    June 15, 2017
    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 Anthogyr Sas

    K Number Device Name
    K141450 AXIOM 2.8
    K131066 AXIOM REG
    K111532 MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
    K102241 ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
    K101913 ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM