510(k) K211701 · QRY Dental Navigation System
X-Guide® Surgical Navigation System
| Applicant | X-Nav Technologies, LLC, Lansdale PA, US |
| Decision | Substantially Equivalent, Feb 1, 2022 |
| Received | Jun 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211701
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2022 | X-NAV Technologies, LLC X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration.
Catalog Number:P010673 Open, Classified |
QRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.