FDA product code LQZ: Device, Jaw Repositioning
LQZ is the FDA product code for device, jaw repositioning. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel. FDA has cleared 27 510(k) submissions under LQZ, 2 in the last five years, from 22 different applicants. The average 510(k) review took 197 days (median 135); 93 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Jaw Repositioning |
| Device class | Class II |
| Regulation | 21 CFR 872.5570 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LQZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 294 |
| 2020 | 2 | 318 |
| 2021 | 1 | 211 |
| 2023 | 1 | 135 |
| 2024 | 1 | 93 |
Compare with all 510(k) review times · Search every LQZ clearance
Top LQZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bryan Keropian Dds | 4 | 2009-06-24 |
| Selane Products, Inc. | 2 | 2017-07-27 |
| Jonathan A. Parker, D.D.S. | 2 | 1996-02-08 |
| Aiomega, LLC | 1 | 2024-02-23 |
| Achaemenid, LLC | 1 | 2023-07-12 |
17 more applicants have LQZ clearances. See the full list in Caduvo.
Most recent LQZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233754 | Aiomega, LLC | AIO Breathe | 2024-02-23 | 93 |
| K230532 | Achaemenid, LLC | RADx Intraoral Appliance for Snoring and Sleep Apnea | 2023-07-12 | 135 |
| K203712 | Biotex, Inc. | The Slide | 2021-07-20 | 211 |
| K191320 | Slow Wave, Inc. | Slow Wave DS8 | 2020-10-02 | 506 |
| K192581 | Advanced Facialdontics, LLC | The NightBlocks Appliance | 2020-01-28 | 131 |
Recalls for LQZ devices
openFDA lists no recalls for product code LQZ.
Frequently asked questions
What is FDA product code LQZ?
LQZ is the FDA product code for device, jaw repositioning. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel.
What device class is LQZ?
Class II, regulation 21 CFR 872.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQZ?
Across 27 cleared submissions the average was 197 days from receipt to decision (median 135).
Which companies have the most LQZ clearances?
Bryan Keropian Dds (4); Selane Products, Inc. (2); Jonathan A. Parker, D.D.S. (2); Aiomega, LLC (1); Achaemenid, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LQZ
- Run a recall and safety report across every LQZ manufacturer
- Watch product code LQZ 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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