The following data is part of a premarket notification filed by Neocis Inc. with the FDA for Yomi Robotic System.
| Device ID | K222750 |
| 510k Number | K222750 |
| Device Name: | Yomi Robotic System |
| Classification | Dental Navigation System |
| Applicant | Neocis Inc. 2800 Biscayne Blvd Suite 600 Miami, FL 33137 |
| Contact | Joshua Davis |
| Correspondent | Joshua Davis Neocis Inc. 2800 Biscayne Blvd Suite 600 Miami, FL 33137 |
| Product Code | QRY |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-12 |
| Decision Date | 2022-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810004900516 | K222750 | 000 |
| 00810004900509 | K222750 | 000 |
| 00810004900493 | K222750 | 000 |
| 00810004900486 | K222750 | 000 |