BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioHorizons Internal Implant

    Reg #: 3017980266 · FEI: 3017980266 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Precision One Medical
    Registration Number
    3017980266
    FEI Number
    3017980266
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2100 Riverchase Ctr Ste 106
    City
    Hoover
    State
    AL
    ZIP
    35244
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042429

    Owner / Operator

    Firm Name
    Precision One Medical
    Operator Number
    10042281
    Address
    3923 Oceanic Dr., Suite 200
    City
    Oceanside
    State
    CA
    Postal Code
    92056
    Country
    US
    Correspondent
    Amose Kim

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    BioHorizons Internal Implant Discontinued - 5.7mm Cover Cap, Machined Discontinued - 5.7MM 3INONE ABUTMENT Internal 5.7 Cover Cap Internal/Single-stage Abutment Screw 3.5mm Custom Temporary Abutment, 1mm Height Discontinued - 4.5mm Cover Cap, Machined Internal 3.5 Regular Emergence 3inOne Abutment Discontinued - 4.5mm Regular Emergence Angled Abutment, Machined Internal 3.5mm Regular Emergence Angled Abutment 4.5mm Custom Temporary Abutment, 3mm Height Internal 4.5mm Regular Emergence Angled Abutment 3.5mm Custom Temporary Abutment, 3mm Height Internal 4.5 Cover Cap Discontinued - 3.5mm 3inOne Abut Regular Emergence, Mach'd Discontinued - 5.7mm Regular Emergence Angled Abutment, Machined Internal 5.7 Regular Emergence 3inOne Abutment Discontinued - 4.5MM 3INONE ABUTMENT Custom Temporary Abutment Sleeve 4.5mm Custom Temporary Abutment, 1mm Height Internal 4.5 Regular Emergence 3inOne Abutment Internal 5.7mm Regular Emergence Angled Abutment Discontinued - 3.5mm Regular Emergence Angled Abutment, Machined Internal 3.5 Cover Cap Discontinued - 3.5mm Cover Cap, Machined

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)