BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AM-20 SD

    Reg #: 3015729 · FEI: 3015729 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    A-dec, Inc.
    Registration Number
    3015729
    FEI Number
    3015729
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2601 Crestview Drive
    City
    Newberg
    State
    OR
    ZIP
    97132
    Country
    US

    Regulatory Submissions

    510(k) Number
    K944711

    Owner / Operator

    Firm Name
    A-dec, Inc.
    Operator Number
    10023499
    Address
    2601 Crestview Drive
    City
    Newberg
    State
    OR
    Postal Code
    97132
    Country
    US
    Correspondent
    Rafael A Vasquez-Villa

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    AM-20 SD AM-5 MW Micro Air Motors: AM-20RM AM-20 MW AM-5 SD

    Establishment Types

    Repack or Relabel Medical Device