Data / Medical devices / Dental Navigation System
Dental Navigation System (QRY): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Dental Navigation System (product code QRY, Class 2, 21 CFR 872.4120). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on October 13, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QRY
- Device class
- 2
- Regulation
- 872.4120
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Canada | 1 |
Makers of Dental Navigation System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| X-Nav Technologies, LLC. | Lansdale, PA, United States | Complaint file establishment, Manufacturer | 3 | August 28, 2026 | 0 | 2 | 0 | api.fda.gov |
| Neocis Inc | Miami, FL, United States | Complaint file establishment, Manufacturer | 1 | December 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Aprios Custom MFG | Vista, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ClaroNav Inc. | Toronto Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.