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

    Conical Ti Base abutments

    K Number: K243521 · Decision May 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    40
    Review Days
    169

    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
    Conical Ti Base abutments
    K Number
    K243521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BioHorizons Implant Systems, Inc.
    Date Received
    November 13, 2024
    Decision Date
    May 1, 2025
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

    Similar 510(k) Clearances

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

    Neodent Scannable Healing Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)

    FDA 510(k)
    FDA Class 2 ·Dental

    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    SIC Abutments including CAD/CAM Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    Elos Accurate® Denture Fixation System

    FDA 510(k)
    FDA Class 2 ·Dental

    ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments

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

    Other Clearances by BioHorizons Implant Systems, Inc.

    K Number Device Name
    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
    K143022 BioHorizons Tapered Internal Implants
    K121787 BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
    Search all 40 clearances from BioHorizons Implant Systems, Inc. →