The following data is part of a premarket notification filed by Overjet, Inc. with the FDA for Overjet Dental Assist.
| Device ID | K210187 |
| 510k Number | K210187 |
| Device Name: | Overjet Dental Assist |
| Classification | System, Image Processing, Radiological |
| Applicant | Overjet, Inc. 560 Harrison Ave, Unit 403 Boston, MA 02118 |
| Contact | Adam Heroux |
| Correspondent | Adam Heroux Overjet, Inc. 560 Harrison Ave, Unit 403 Boston, MA 02118 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2021-05-19 |