Innobyte Full-Arch Mouthpiece Sensor INNOMP01

GUDID D091INNOMP010

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.

Kube Innovation Inc

Dynamometer attachment

• Primary Device ID: D091INNOMP010
• NIH Device Record Key: 7c729fb5-dd33-49ba-9c88-62238c048717
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innobyte Full-Arch Mouthpiece Sensor
• Version Model Number: 1.0
• Catalog Number: INNOMP01
• Company DUNS: 201096437
• Company Name: Kube Innovation Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D091INNOMP010 [Primary]

FDA Product Code

• LBB: Dynamometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-19
• Device Publish Date: 2022-01-11

Devices Manufactured by Kube Innovation Inc

• D091INNOCP030 - Innobyte Bilateral Clinical Package: 2023-07-04 The Innobyte is a medical device for dental clinicians in the quantitative evaluations of a patient’s bite strength. Includes
• D091INNOMP030 - Innobyte Bilateral Mouthpiece Replacement: 2023-07-04 The Innobyte Bilateral Mouthpiece Sensor is a measurement medical device for dental clinicians in the quantitative evaluations o
• D091INNOCA010 - Innobyte Clinical Package: 2022-01-19 The Innobyte is a measurement medical device for dental clinicians in the quantitative evaluations of a patient’s bite strengt
• D091INNOMP010 - Innobyte Full-Arch Mouthpiece Sensor: 2022-01-19The 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.
• D091INNOMP010 - Innobyte Full-Arch Mouthpiece Sensor: 2022-01-19 The Innobyte Full-Arch Mouthpiece Sensor is a measurement medical device for dental clinicians in the quantitative evaluations o