BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ratchet

    Reg #: 3009201148 · FEI: 3009201148 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PRECISION ONE MEDICAL
    Registration Number
    3009201148
    FEI Number
    3009201148
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3923 OCEANIC DR STE 200
    City
    Oceanside
    State
    CA
    ZIP
    92056
    Country
    US

    Regulatory Submissions

    510(k) Number
    K972313

    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

    Ratchet External 3.5mm Angled Abutment, Hexed Discontinued - Supersede to PXABCC - Cover Cap, AFS Drill Extender Starter Drill External 4mm Angled Abutment, Hexed

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)