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

    BioHorizons Tapered Internal Implants

    K Number: K143022 · Decision Jan 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    333
    Registration Numbers
    333
    Same Product Code
    1516
    Applicant Total
    32
    Review Days
    79

    Basic Information

    Device Name
    BioHorizons Tapered Internal Implants
    K Number
    K143022
    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
    October 21, 2014
    Decision Date
    January 8, 2015
    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
    K151621 BioHorizons CAD/CAM Abutments
    K121787 BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
    K103291 BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
    K103691 BIOHORIZONS ABUTMENTS FOR ZIMMER
    K100985 BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
    K093321 BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
    K081818 BIOLOK MICRO-LOK IMPLANT SYSTEM
    K073282 BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
    K073268 BIOHORIZONS INTERNAL IMPLANT SYSTEM
    K071638 BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
    Search all 32 clearances from BIOHORIZONS IMPLANT SYSTEMS, INC. →