BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOHORIZONS IMPLANT SYSTEMS INC.

    Reg #: 1060818 · FEI: 1000592496 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    41
    Establishment Types
    4
    Classifications
    8

    Registration Details

    Registration Name
    BIOHORIZONS IMPLANT SYSTEMS INC.
    Registration Number
    1060818
    FEI Number
    1000592496
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2300 RIVERCHASE CENTER
    City
    BIRMINGHAM
    State
    AL
    ZIP
    35244
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071638

    Owner / Operator

    Firm Name
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Operator Number
    9024113
    Address
    2300 RIVERCHASE CENTER, --
    City
    Birmingham
    State
    AL
    Postal Code
    35244
    Country
    US
    Correspondent
    Jared Cooper

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Accessories, Implant, Dental, Endosseous NDP
    Screw, Fixation, Intraosseous DZL
    Dental Abutment Design Software For Dental Laboratory PNP
    Crown, Preformed ELZ
    Plate, Bone JEY
    Platelet And Plasma Separator For Bone Graft Handling ORG

    Proprietary Names

    BioHorizons Tapered Internal Implant System Tapered Pro Conical Implant System BIOHORIZONS DENTAL IMPLANT ACCESSORIES Biolok Micro-Lok Implant System BioHorizons Simple Solutions with Laser-Lok BioHorizons Abutments for Zimmer Intra-Lock Dental Implants The Autotac System BioHorizons Dental Implant System BioHorizons Tapered Internal Plus Implants Mini Drive-Lock Dental Implant System Intra-Lock Dental Implants with Blossom Intra-Lock Angled Prosthetic Abutments ACE BONE SCREW TACKING KIT Milo Dental Implant System BioHorizons Tapered Internal Implants The Maestro System BioHorizons Laser-Lok 3 Implant System Tapered IM Implants BioHorizons Plastic Temporary Abutments SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment Conical Ti Base Abutments Intra-Lock Endosseous Implants MRI compatibility for existing BioHorizons dental implants and abutments Maestro System BioHorizons Single-stage Implant System BioHorizons Internal Implant System Intra-Lock Dental Implants with Blossom 3.4mm Implant Angled Abutments BioHorizons Single-stage Implant Multi-unit Abutments for CONELOG BIOHORIZONS COMFORT CAP BioHorizons CAD/CAM Abutments BioHorizons Tapered Short Implants Mini Drive-Lock Dental Implant System Prosthetics CAD/CAM Bars ACE SURIGICAL TRU-FIX IMPLANT SYSTEM MINIBONEPLATE SYSTEM The Autotac System Titanium Tack Intra-Lock Op Dental Implants Intra-Spin System The Prodigy System Dental Implants

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility