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 Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Dynamometer attachment Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece Gnathodynamometer mouthpiece

• 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