BRWClass I

Protector, Dental

21 CFR 868.5820 / Anesthesiology

BRW is the FDA product code for Protector, Dental, a class I device type, regulated under 21 CFR 868.5820. As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 1994-12-07, and no recalls.

Classification record

Product code: BRW
Device name: Protector, Dental
Regulation: 21 CFR 868.5820
Device class: Class I
Review panel: Anesthesiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code BRW

By decision year

3 clearances under product code BRW with a decision year between 1985 and 1994, 1994 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code BRW by decision year
Year	Clearances
1985	1
1994	2

Applicants with the most clearances

Product code BRW

Applicants holding the most 510(k) clearances under product code BRW
Applicant	Clearances
Catco Medical, Inc.	1
Edward O. Goodwich	1
Fvtnks	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 72 companies shown, in name order

Recent clearances

Product code BRW

Recent recalls

Product code BRW

FDA records show no recalls under product code BRW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)