FDA product code QRY: Dental Navigation System
QRY is the FDA product code for dental navigation system. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under QRY, 5 in the last five years, from 2 different applicants. The average 510(k) review took 185 days (median 217); 239 days on average over the last three years. FDA has posted 3 recalls for QRY devices, 3 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Dental Navigation System |
| Device class | Class II |
| Regulation | 21 CFR 872.4120 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for QRY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 3 | 148 |
| 2024 | 1 | 217 |
| 2026 | 1 | 261 |
Compare with all 510(k) review times · Search every QRY clearance
Top QRY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| X-Nav Technologies, LLC | 3 | 2026-08-28 |
| Neocis, Inc. | 2 | 2022-12-08 |
Most recent QRY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253954 | X-Nav Technologies, LLC | X-Guide Surgical Navigation System | 2026-08-28 | 261 |
| K232148 | X-Nav Technologies, LLC | X-Guide Surgical Navigation System | 2024-02-21 | 217 |
| K222750 | Neocis, Inc. | Yomi Robotic System | 2022-12-08 | 87 |
| K222049 | Neocis, Inc. | Yomi Robotic System | 2022-11-04 | 115 |
| K211701 | X-Nav Technologies, LLC | X-Guide® Surgical Navigation System | 2022-02-01 | 243 |
Recalls for QRY devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-03-04.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code QRY?
QRY is the FDA product code for dental navigation system. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel.
What device class is QRY?
Class II, regulation 21 CFR 872.4120. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRY?
Across 5 cleared submissions the average was 185 days from receipt to decision (median 217).
Which companies have the most QRY clearances?
X-Nav Technologies, LLC (3); Neocis, Inc. (2).
Have QRY devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2024-03-04.
Next steps
- Run an FDA pathway report with predicate devices for product code QRY
- Run a recall and safety report across every QRY manufacturer
- Watch product code QRY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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