K232148 is an FDA 510(k) clearance for the X-Guide Surgical Navigation System. This device is classified as a Dental Navigation System (Class II - Special Controls, product code QRY).
Submitted by X-Nav Technologies, LLC (Lansdale, US). The FDA issued a Cleared decision on February 21, 2024, 217 days after receiving the submission on July 19, 2023.
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 | K232148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2023 |
| Decision Date | February 21, 2024 |
| Days to Decision | 217 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. |