FDA product code POW: Crown And Bridge, Long-Term Temporary, Resin
POW is the FDA product code for crown and bridge, long-term temporary, resin. It is a Class II device, regulated under 21 CFR 872.3770 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under POW, 1 in the last five years. The average 510(k) review took 60 days (median 60).
Definition
For the fabrication of long-term temporary crowns and bridges
Classification
| Field | Value |
|---|---|
| Device name | Crown And Bridge, Long-Term Temporary, Resin |
| Device class | Class II |
| Regulation | 21 CFR 872.3770 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for POW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 60 |
Compare with all 510(k) review times · Search every POW clearance
Top POW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Voco GmbH | 1 | 2023-07-31 |
Most recent POW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231591 | Voco GmbH | V-Print c&b temp | 2023-07-31 | 60 |
Recalls for POW devices
openFDA lists no recalls for product code POW.
Frequently asked questions
What is FDA product code POW?
POW is the FDA product code for crown and bridge, long-term temporary, resin. It is a Class II device, regulated under 21 CFR 872.3770 and reviewed by the Dental panel.
What device class is POW?
Class II, regulation 21 CFR 872.3770. Typical premarket route: 510(k).
How long does a 510(k) take for product code POW?
Across 1 cleared submissions the average was 60 days from receipt to decision (median 60).
Which companies have the most POW clearances?
Voco GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code POW
- Run a recall and safety report across every POW manufacturer
- Watch product code POW 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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