K211701 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 1, 2022, 243 days after receiving the submission on June 3, 2021.
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 | K211701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2021 |
| Decision Date | February 01, 2022 |
| Days to Decision | 243 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. |