BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHOSELECT

    Reg #: 3010111497 · FEI: 3010111497 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ORTHOSELECT
    Registration Number
    3010111497
    FEI Number
    3010111497
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    772 E Utah Valley Dr Ste 100
    City
    American Fork
    State
    UT
    ZIP
    84003
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192701

    Owner / Operator

    Firm Name
    OrthoSelect
    Operator Number
    10091189
    Address
    831 E 340 S, Suite 170, Suite 170
    City
    American Fork
    State
    UT
    Postal Code
    84003
    Country
    US

    Products

    Device Name Product Code
    Indirect Bonding Tray QJJ
    Orthodontic Software PNN
    System, Image Processing, Radiological LLZ

    Proprietary Names

    DIBS AI Indirect Bonding Tray DIBS AI

    Establishment Types

    Manufacture Medical Device