| Primary Device ID | 00860005586349 |
| NIH Device Record Key | 80c382f7-93a2-44f0-8597-e0e0d674417b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Overjet DI System |
| Version Model Number | v1 |
| Company DUNS | 116916753 |
| Company Name | Overjet, 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005586349 [Primary] |
| LMD | System, Digital Image Communications, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-20 |
| Device Publish Date | 2024-11-12 |
| 00860005586301 - Overjet Dental Assist | 2024-11-20 |
| 00860005586318 - Overjet Caries Assist | 2024-11-20 |
| 00860005586325 - Overjet Calculus Assist | 2024-11-20 |
| 00860005586332 - Overjet Periapical Radiolucency Assist | 2024-11-20 |
| 00860005586349 - Overjet DI System | 2024-11-20 |
| 00860005586349 - Overjet DI System | 2024-11-20 |
| 00860005586356 - Overjet Charting Assist | 2024-11-20 |
| 00860005586363 - Overjet Caries Assist-Pediatric | 2024-11-20 |
| 00860005586370 - Overjet Image Enhancement Assist | 2024-11-20 |