BEUDAMED
    FDA Registration Active 🇺🇸 United States

    External 3.5mm 3inOne Abutment, Hexed

    Reg #: 3017980266 · FEI: 3017980266 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    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
    K022795

    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
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    External 3.5mm 3inOne Abutment, Hexed External 5mm 3inOne Abutment, Hexed Discontinued - 4mm Ti-N Angled Esthetic Abutment, Machined External 6mm 3inOne Abutment, Hexed External 3.5mm Angled Esthetic Abutment, Hexed External 5mm Angled Esthetic Abutment, Hexed Discontinued - 3.5mm Ti-N Angled Esthetic Abutment, Machined External 4mm Angled Esthetic Abutment, Hexed External 4mm 3inOne Abutment, Hexed

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)