Innobyte Bilateral Clinical Package

Basic Information

• Brand Name: Innobyte Bilateral Clinical Package
• Primary DI: D091INNOCP030
• Version / Model: 1.0
• Catalog Number: INNOCP03
• 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: 2
• Public Version Date: 2024-07-25
• Public Version Status: Update
• Public Device Record Key: 42a26543-e182-492e-b465-50e211baf987

Device Description

The Innobyte is a medical device for dental clinicians in the quantitative evaluations of a patient’s bite strength. Includes; 1 Innobyte Handpiece, 1 Mouthpiece Sensor, 100 Protective Sleeves, Wall-Mount USB charger, associated cables, 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
66292	Gnathodynamometer	An electrically-powered instrument intended to measure the maximal bite force produced when closing the jaw/mouth. It consists of a mouthpiece on which the patient bites, which transmits the measured force to sensors within a connected control unit for display on a digital user interface. This is a reusable device.	No	Active
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
66294	Bite block cover	A disposable, intraoral device in the form of a transparent sleeve intended to cover a bite block (typically a dental x-ray system bite block or gnathodynamometer mouthpiece), to prevent cross-contamination between patients. Neither the bite block nor mouthpiece are included with the cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D091INNOCP030	HIBCC

Customer Contacts

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