510(k) clearance
Yomi S Robotic System
- 510(k) number
- K261321
- Applicant
- Neocis, Inc.
- Decision date
- Oct 13, 2026
- Date received
- Apr 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QRY
- Device type
- Dental Navigation System
- Device class
- Class II
- Regulation
- 21 CFR 872.4120
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Miami, FL, US