BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Internal 4.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok

    Reg #: 3017980266 · FEI: 3017980266 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    2

    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
    K071638

    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
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    Internal 4.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok Internal 4.5mm Angled Esthetic Abutment 3.5mm Dual Purpose Abutment (Regular Emergence) 5.7mm 20 Degree Angled Abutment (Regular Emergence) Internal 3.5mm Straight Esthetic Abutment, Laser-Lok 5.7mm Dual Purpose Abutment (Regular Emergence) Internal 5.7mm Straight Esthetic Abutment, 3mm Buccal Discontinued - 4.5mm Internal Angled Esthetic Abutment, Machined Discontinued - Internal 4.5mm Straight Esthetic Abutment, 3mm Margin Machined 4.5mm 20 Degree Angled Abutment (Regular Emergence) Internal/Single-stage Abutment Screw Internal 4.5mm Straight Esthetic Abutment, Laser-Lok Discontinued - Internal 3.5mm Straight Esthetic Abutment, 3mm Margin Machined Discontinued - 5.7mm Internal Straight Esthetic Abutment, Machined BioHorizons Tapered Internal Implant Discontinued - 3.5mm Internal Angled Esthetic Abutment, Machined 4.5mm Dual Purpose Abutment (Regular Emergence) Internal 5.7mm Straight Esthetic Abutment, Laser-Lok Internal 5.7mm Angled Esthetic Abutment, Laser-Lok Discontinued - 3.5mm Internal Straight Esthetic Abutment, Machined Internal 3.5mm Angled Esthetic Abutment Internal 5.7mm Angled Esthetic Abutment Discontinued - 4.5mm Internal Straight Esthetic Abutment Internal 3.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok Discontinued - 5.7mm Internal Angled Esthetic Abutment Internal 4.5mm Angled Esthetic Abutment, Laser-Lok Internal 3.5mm Angled Esthetic Abutment, Laser-Lok Internal 4.5mm Straight Esthetic Abutment Internal 4.5mm Straight Esthetic Abutment, 3mm Buccal 3.5mm 20 Degree Angled Abutment (Regular Emergence) Discontinued - 3.5mm 3inOne Abut Regular Emergence, Mach'd Internal 5.7mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok Internal 3.5mm Straight Esthetic Abutment Internal 3.5 Regular Emergence 3inOne Abutment Internal 5.7mm Straight Esthetic Abutment Discontinued - Internal 5.7mm Straight Esthetic Abutment, 3mm Margin Machined Internal 3.5mm Straight Esthetic Abutment, 3mm Buccal

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)