BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Acceledent Optima

    DI: 00852673007240 · Model: ASM-20031 · PROPEL ORTHODONTICS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Acceledent Optima
    Primary DI
    00852673007240
    Version / Model
    ASM-20031
    Company Name
    PROPEL ORTHODONTICS LLC
    Labeler DUNS
    117334253
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-31
    Public Version
    3
    Public Version Date
    2023-05-12
    Public Version Status
    Update
    Public Device Record Key
    55e58f0a-661d-40b0-bb42-a9ed1588e847
    Distribution End Date
    2023-05-11

    Device Description

    AcceleDent Optima is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and aligners to help facilitate minor anterior tooth movement.

    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OYH Orthodontic Vibratory Accessory

    GMDN Terms

    Code Name
    62310 Orthodontic vibrator

    Identifiers

    Type ID
    Primary 00852673007240