BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Empower Clear

    DI: 00190746001048 · Model: 1485-22-4311HD · AMERICAN ORTHODONTICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Empower Clear
    Primary DI
    00190746001048
    Version / Model
    1485-22-4311HD
    Catalog Number
    1485-22-4311HD
    Company Name
    AMERICAN ORTHODONTICS CORPORATION
    Labeler DUNS
    044668515
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-20
    Public Version
    5
    Public Version Date
    2020-03-19
    Public Version Status
    Update
    Public Device Record Key
    f94a2d8d-36ba-4065-a0bd-116dad5327bc
    Distribution End Date
    2020-03-18

    Device Description

    COSMETIC SL EMPOWER CLEAR INTERACT LR CUSPID 022 T-11 A+7 R=0 W/HK DIST

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NJM Bracket, ceramic, orthodontic

    GMDN Terms

    Code Name
    58818 Self-ligating orthodontic bracket

    Identifiers

    Type ID
    Primary 00190746001048

    Customer Contacts

    Phone
    +1(800)558-7687
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K122753 000