FDA product code BRW: Protector, Dental
BRW is the FDA product code for protector, dental. It is a Class I device, regulated under 21 CFR 868.5820 and reviewed by the Anesthesiology panel. FDA has cleared 3 510(k) submissions under BRW, from 3 different applicants. The average 510(k) review took 70 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Protector, Dental |
| Device class | Class I |
| Regulation | 21 CFR 868.5820 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BRW clearance
Top BRW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Catco Medical, Inc. | 1 | 1994-12-07 |
| Fvtnks | 1 | 1994-01-05 |
| Edward O. Goodwich | 1 | 1985-09-18 |
Most recent BRW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945727 | Catco Medical, Inc. | CATCO NEONATAL PALATE GUARD | 1994-12-07 | 15 |
| K935713 | Fvtnks | WILEY/ESPOSITO DENTAL GUARD | 1994-01-05 | 36 |
| K851640 | Edward O. Goodwich | TIP TOLEDO INCISOR PROTECTOR | 1985-09-18 | 160 |
Recalls for BRW devices
openFDA lists no recalls for product code BRW.
Frequently asked questions
What is FDA product code BRW?
BRW is the FDA product code for protector, dental. It is a Class I device, regulated under 21 CFR 868.5820 and reviewed by the Anesthesiology panel.
What device class is BRW?
Class I, regulation 21 CFR 868.5820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BRW?
Across 3 cleared submissions the average was 70 days from receipt to decision (median 36).
Which companies have the most BRW clearances?
Catco Medical, Inc. (1); Fvtnks (1); Edward O. Goodwich (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BRW
- Run a recall and safety report across every BRW manufacturer
- Watch product code BRW 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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