BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OraShape Aligners

    Reg #: 3024490167 · FEI: 3024490167 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    GECKO LABS, LLC
    Registration Number
    3024490167
    FEI Number
    3024490167
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13840 Stowe Dr.
    City
    Poway
    State
    CA
    ZIP
    92064
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211537

    Owner / Operator

    Firm Name
    Gecko Labs, LLC
    Operator Number
    10086104
    Address
    13840 Stowe Dr.
    City
    Poway
    State
    CA
    Postal Code
    92064
    Country
    US
    Correspondent
    Ben Bradley

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    OraShape Aligners GT FLEX Aligners QuickAligners Aligners

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device