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
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    40
    Review Days
    79

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.

    MegaGen Zygoma Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    INOSS System

    FDA 510(k)
    FDA Class 2 ·Dental

    Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

    FDA 510(k)
    FDA Class 2 ·Dental

    Adin Long Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    ZENEX Implant System_Short (R-System)

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    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
    K182070 BioHorizons Tapered IM Implants
    K180998 BioHorizons CAD/CAM Bars
    K172576 BioHorizons Tapered Short Implants
    K151621 BioHorizons CAD/CAM Abutments
    K121787 BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
    Search all 40 clearances from BioHorizons Implant Systems, Inc. →