The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Odonto-scope.
| Device ID | K822562 |
| 510k Number | K822562 |
| Device Name: | ODONTO-SCOPE |
| Classification | Microscope, Surgical, General & Plastic Surgery |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSO |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-24 |
| Decision Date | 1982-10-06 |