FDA product code PWL: Oral Surgery Tray
PWL is the FDA product code for oral surgery tray. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. Devices under PWL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 15 recalls for PWL devices, 15 initiated in the last five years.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Oral Surgery Tray |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for PWL devices
15 product recalls in 1 recall events; 15 initiated in the last five years and 15 still open. Most recent: 2022-11-02.
| Year | Recalls |
|---|---|
| 2022 | 15 |
Frequently asked questions
What is FDA product code PWL?
PWL is the FDA product code for oral surgery tray. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is PWL?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
Have PWL devices been recalled?
Yes: 15 product recalls across 1 recall events; the most recent began 2022-11-02.
Next steps
- Run an FDA pathway report with predicate devices for product code PWL
- Run a recall and safety report across every PWL manufacturer
- Watch product code PWL 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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