BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GEM

    Reg #: 3007007357 · FEI: 3007007357 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Handpiece Headquarters
    Registration Number
    3007007357
    FEI Number
    3007007357
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    620 S. Placentia Ave.
    City
    Placentia
    State
    CA
    ZIP
    92870
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221955

    Owner / Operator

    Firm Name
    Handpiece Headquarters
    Operator Number
    10028763
    Address
    620 S. Placentia Ave.
    City
    Placentia
    State
    CA
    Postal Code
    92870
    Country
    US

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    GEM Carina

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility