BEUDAMED
    FDA Registration Active 🇺🇸 United States

    REF-LINE

    Reg #: 3004491043 · FEI: 3004491043 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PRIMOTEC LLC
    Registration Number
    3004491043
    FEI Number
    3004491043
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    215 Westport Ave
    City
    Norwalk
    State
    CT
    ZIP
    06851
    Country
    US

    Regulatory Submissions

    510(k) Number
    K926070

    Owner / Operator

    Firm Name
    Primotec LLC
    Operator Number
    10041713
    Address
    360 Westport Ave.
    City
    Norwalk
    State
    CT
    Postal Code
    06851
    Country
    US
    Correspondent
    Christopher Urist

    Products

    Device Name Product Code
    Denture, Plastic, Teeth ELM

    Proprietary Names

    REF-LINE

    Establishment Types

    Repack or Relabel Medical Device