| Primary Device ID | D091INNOMP030 |
| NIH Device Record Key | 806183c1-ca56-4d06-9542-56a9d01dd0fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Innobyte Bilateral Mouthpiece Replacement |
| Version Model Number | 1.0 |
| Catalog Number | INNOMP03 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 | 2023-07-04The 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. |
| 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 | 2022-01-19 The Innobyte Full-Arch Mouthpiece Sensor is a measurement medical device for dental clinicians in the quantitative evaluations o |