K222049 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 November 4, 2022, 115 days after receiving the submission on July 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 | K222049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 115 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. |