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

    BioHorizons Tapered IM Implants

    K Number: K182070 · Decision Oct 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    40
    Review Days
    70

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    Basic Information

    Device Name
    BioHorizons Tapered IM Implants
    K Number
    K182070
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BioHorizons Implant Systems, Inc.
    Date Received
    August 1, 2018
    Decision Date
    October 10, 2018
    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 BioHorizons Implant Systems, Inc.

    K Number Device Name
    K243521 Conical Ti Base abutments
    K240531 SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment
    K240187 Tapered Pro Conical Implant System
    K223697 MRI compatibility for existing BioHorizons dental implants and abutments
    K203252 Multi-unit Abutments for CONELOG
    K180998 BioHorizons CAD/CAM Bars
    K172576 BioHorizons Tapered Short Implants
    K151621 BioHorizons CAD/CAM Abutments
    K143022 BioHorizons Tapered Internal Implants
    K121787 BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
    Search all 40 clearances from BioHorizons Implant Systems, Inc. →