Innobyte Bilateral Mouthpiece Replacement

Basic Information

• Brand Name: Innobyte Bilateral Mouthpiece Replacement
• Primary DI: D091INNOMP030
• Version / Model: 1.0
• Catalog Number: INNOMP03
• Company Name: Kube Innovation Inc
• Labeler DUNS: 201096437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-26
• Public Version: 1
• Public Version Date: 2023-07-04
• Public Version Status: New
• Public Device Record Key: 806183c1-ca56-4d06-9542-56a9d01dd0fe

Device Description

The Innobyte Bilateral 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): 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: 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	Medical Specialty	Regulation #	Device Class
LBB	Dynamometer, Ac-Powered	Orthopedic	888.1240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66293	Gnathodynamometer mouthpiece	A mouthpiece intended to be attached to a gnathodynamometer control unit (not included) to measure maximal bite force. It is typically filled with a fluid medium which transmits the measured force to sensors in the control unit when force is applied by closing the jaw/mouth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D091INNOMP030	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]