GRIND GUARD


Device Classification Name

mouthguard, over-the-counter

510(k) Number K073446
Device Name GRIND GUARD
Applicant
ARCHTEK, INC.
1705 south capitol of texas hw
austin, 
TX 
78746

Applicant Contact ian p gordon
Correspondent
ARCHTEK, INC.
1705 south capitol of texas hw
austin, 
TX 
78746

Correspodent Contact ian p gordon
Classification Product Code
OBR  
Date Received 12/07/2007
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No