BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vivera™ 3D retainers

    DI: 00816063022923 · Model: 5016 · Align Technology, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Vivera™ 3D retainers
    Primary DI
    00816063022923
    Version / Model
    5016
    Company Name
    Align Technology, Inc.
    Labeler DUNS
    013831768
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-15
    Public Version
    1
    Public Version Date
    2025-04-23
    Public Version Status
    New
    Public Device Record Key
    bf00df22-b51e-4163-b0b5-53a04a21e880

    Device Description

    Vivera™ 3D retainers are 3D printed retainers indicated for maintaining and preventing movement of a patient's dentition.

    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
    Yes
    Has Serial Number
    No
    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
    DYT Maintainer, Space Preformed, Orthodontic

    GMDN Terms

    Code Name
    35310 Orthodontic retainer

    Identifiers

    Type ID
    Primary 00816063022923