BRW — Protector, Dental Class I

FDA Device Classification

FDA product code BRW covers "Protector, Dental", a Class I medical device regulated under 21 CFR 868.5820. Submissions are reviewed by the Anesthesiology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
BRW
Device Class
Class I
Regulation Number
868.5820
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K945727catco medicalCATCO NEONATAL PALATE GUARDDecember 7, 1994
K935713fvtnksWILEY/ESPOSITO DENTAL GUARDJanuary 5, 1994
K851640edward o. goodwichTIP TOLEDO INCISOR PROTECTORSeptember 18, 1985