510(k) K261321
K261321 is an FDA 510(k) premarket notification submitted by Neocis, Inc. for the device "Yomi S Robotic System". The FDA issued a decision of Substantially Equivalent on Oct 13, 2026. The device falls under product code QRY (Dental Navigation System), a Class II device regulated under 21 CFR 872.4120. Neocis, Inc. has 18 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 13, 2026
- Date Received
- Apr 22, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dental Navigation System
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type
- 510(k)
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.