BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    PALTOP DENTAL IMPLANT - STERILE ACCESSORIES

    K Number: K131451 · Decision Aug 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    7
    Review Days
    94

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    Basic Information

    Device Name
    PALTOP DENTAL IMPLANT - STERILE ACCESSORIES
    K Number
    K131451
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paltop Advanced Dental Solutions, Ltd.
    Date Received
    May 20, 2013
    Decision Date
    August 22, 2013
    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 Paltop Advanced Dental Solutions, Ltd.

    K Number Device Name
    K243983 Paltop Dental Implant System
    K232740 Paltop Short Implants
    K220200 Paltop Conical Implant System
    K210117 Paltop Narrow Implant
    K130462 PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT
    K112795 PALTOP DENTAL IMPLANT SYSTEM