QRY
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dental Navigation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4120
- Medical specialty
- Dental
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| X-Guide Surgical Navigation System (K232148) | X-Nav Technologies, LLC | 2024-02-21 |
| Yomi Robotic System (K222750) | Neocis, Inc. | 2022-12-08 |
| Yomi Robotic System (K222049) | Neocis, Inc. | 2022-11-04 |
| X-Guide® Surgical Navigation System (K211701) | X-Nav Technologies, LLC | 2022-02-01 |
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Every clearance here is in the API, with alerts when new ones post.