Innobyte Bilateral Clinical Package
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…
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.
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suga Electronics (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Suga Technology (Dongguan) Co.. Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Kube Innovation Inc., Canada |
|---|---|
| FDA product code | LBB |
| Device type | Dynamometer, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1240 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-26 |
| Record revised | 2024-07-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kinvent | Kinvent Hellas | 4 |
| SR-3053 | RED OAK Instruments, LLC | 2 |
| Innobyte Full-Arch Mouthpiece Sensor | Kube Innovation Inc. | 1 |
| KForce Bubble | Kinvent Biomecanique | 1 |
| Innobyte Clinical Package | Kube Innovation Inc. | 1 |
| AcroPinch™ Device | Axogen Corporation | 1 |
| ActivForce 2 | Activbody | 1 |
| microFET Pinch | Hoggan Scientific L.L.C. | 1 |
| Innobyte Bilateral Mouthpiece Replacement | Kube Innovation Inc. | 1 |
| microfet2 | Hoggan Scientific L.L.C. | 1 |
| Eforto | UniWeb BV | 1 |
| KForce Muscle Controller | Kinvent Biomecanique | 1 |
Showing 12 of 19. All products under Dynamometer, Ac-Powered
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.