FDA product code PLH: Orthodontic Led Accessory
PLH is the FDA product code for orthodontic led accessory. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under PLH, 1 in the last five years, from 2 different applicants. The average 510(k) review took 168 days (median 168).
Definition
Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Classification
| Field | Value |
|---|---|
| Device name | Orthodontic Led Accessory |
| Device class | Class II |
| Regulation | 21 CFR 872.5470 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PLH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 70 |
Compare with all 510(k) review times · Search every PLH clearance
Top PLH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biolux Technology GmbH | 1 | 2023-06-09 |
| Biolux Research , Ltd. | 1 | 2015-07-24 |
Most recent PLH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230905 | Biolux Technology GmbH | OrthoPulse 2.0E (OPi2E-100) | 2023-06-09 | 70 |
| K143120 | Biolux Research , Ltd. | OrthoPulse | 2015-07-24 | 267 |
Recalls for PLH devices
openFDA lists no recalls for product code PLH.
Frequently asked questions
What is FDA product code PLH?
PLH is the FDA product code for orthodontic led accessory. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel.
What device class is PLH?
Class II, regulation 21 CFR 872.5470. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLH?
Across 2 cleared submissions the average was 168 days from receipt to decision (median 168).
Which companies have the most PLH clearances?
Biolux Technology GmbH (1); Biolux Research , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PLH
- Run a recall and safety report across every PLH manufacturer
- Watch product code PLH 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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