BRUX MOUTHGUARDS


Device Classification Name

mouthguard, over-the-counter

510(k) Number K111310
Device Name BRUX MOUTHGUARDS
Applicant
DENTAL ARTE, INC.
7046 owl’s nest terr
braderdon, 
FL 
34203

Applicant Contact carolyn primus
Correspondent
DENTAL ARTE, INC.
7046 owl’s nest terr
braderdon, 
FL 
34203

Correspodent Contact carolyn primus
Classification Product Code
OBR  
Date Received 05/10/2011
Decision Date 12/08/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No