BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ortek ECD

    Reg #: 3004498471 · FEI: 3004498471 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ORTEK THERAPEUTICS, INC.
    Registration Number
    3004498471
    FEI Number
    3004498471
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1188 Willis Ave #224
    City
    Albertson
    State
    NY
    ZIP
    11507
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170822

    Owner / Operator

    Firm Name
    Ortek Therapeutics, Inc.
    Operator Number
    10062451
    Address
    1188 Willis Ave #224
    City
    Albertson
    State
    NY
    Postal Code
    11507
    Country
    US
    Correspondent
    Mitch Goldberg

    Products

    Device Name Product Code
    Device, Caries Detection LFC
    Laser, Fluorescence Caries Detection NBL

    Proprietary Names

    Ortek ECD

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device