Surgical devices · 21 CFR 872 Subpart E
Dental Navigation System
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.
- Companies listing it
- 44 makers
- Brands and models
- 12
- 510(k) clearances
- 66 in five years
- FDA name
- Dental Navigation System
510(k) clearances per year, 1976–2026
Companies that list QRY
4 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Neocis | United States | Maker | Yomi Robotic System · Yomi S Robotic System | 19 | 2026 |
| X-NAV Technologies, LLC. | United States | Maker | IconiX · IconiX AI · Straight Cuts · ToolTrace · +5 | 6 | 2026 |
| ClaroNav Inc. | Canada | Maker | Navident | 3 | 2024 |
| Pacific Plastics Injection Molding | United States | Maker | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 13 Oct 2026 | K261321 | Yomi S Robotic System | Neocis |
| 28 Aug 2026 | K253954 | X-Guide Surgical Navigation System | X-NAV Technologies, LLC. |
| 21 Feb 2024 | K232148 | X-Guide Surgical Navigation System | X-NAV Technologies, LLC. |
| 8 Dec 2022 | K222750 | Yomi Robotic System | Neocis |
| 4 Nov 2022 | K222049 | Yomi Robotic System | Neocis |
| 1 Feb 2022 | K211701 | X-Guide® Surgical Navigation System | X-NAV Technologies, LLC. |
Official records: FDA product classification for QRY · 21 CFR 872.4120.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026