BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EXPRESS ALIGNER TREATMENT

    Reg #: 3032193293 · FEI: 3032193293 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ORTHO DENTAL LAB, LLC
    Registration Number
    3032193293
    FEI Number
    3032193293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1530 Antioch Pike
    City
    Antioch
    State
    TN
    ZIP
    37013
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212496

    Owner / Operator

    Firm Name
    Ortho Dental Lab, LLC
    Operator Number
    10091367
    Address
    1530 Antioch Pike
    City
    Antioch
    State
    TN
    Postal Code
    37013
    Country
    US

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    EXPRESS ALIGNER TREATMENT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device