K222750 is an FDA 510(k) clearance for the Yomi Robotic System. This device is classified as a Dental Navigation System (Class II - Special Controls, product code QRY).
Submitted by Neocis, Inc. (Miami, US). The FDA issued a Cleared decision on December 8, 2022, 87 days after receiving the submission on September 12, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120. Intended To Provide Real-time Guidance On The Orientation And Location Of The Dental Instrument Relative To The Patient's Anatomy For General Dentistry Procedures..
| 510(k) Number | K222750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2022 |
| Decision Date | December 08, 2022 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | QRY - Dental Navigation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |
| Definition | Intended To Provide Real-time Guidance On The Orientation And Location Of The Dental Instrument Relative To The Patient's Anatomy For General Dentistry Procedures. |