BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Innobyte Full-Arch Mouthpiece Sensor

    DI: D091INNOMP010 · Model: 1.0 · Kube Innovation Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Innobyte Full-Arch Mouthpiece Sensor
    Primary DI
    D091INNOMP010
    Version / Model
    1.0
    Catalog Number
    INNOMP01
    Company Name
    Kube Innovation Inc
    Labeler DUNS
    201096437
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-11
    Public Version
    2
    Public Version Date
    2023-06-08
    Public Version Status
    Update
    Public Device Record Key
    7c729fb5-dd33-49ba-9c88-62238c048717

    Device Description

    The Innobyte Full-Arch Mouthpiece Sensor is a measurement medical device for dental clinicians in the quantitative evaluations of a patient’s full arch bite strength. Must be used with Innobyte Handpiece and Protective Sleeves for proper functioning. Includes: 1 Mouthpiece, Operations Manuals and Guides, & One Year Parts and Labor Warranty.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LBB Dynamometer, Ac-Powered

    GMDN Terms

    Code Name
    66293 Gnathodynamometer mouthpiece

    Identifiers

    Type ID
    Primary D091INNOMP010