PROTECH DENT


Device Classification Name

mouthguard, over-the-counter

510(k) Number K121272
Device Name PROTECH DENT
Applicant
AKERVALL TECHNOLOGIES INC
5520 stone valley drive
ann arbor, 
MI 
48105

Applicant Contact sassa akervall
Correspondent
AKERVALL TECHNOLOGIES INC
5520 stone valley drive
ann arbor, 
MI 
48105

Correspodent Contact sassa akervall
Classification Product Code
OBR  
Date Received 04/27/2012
Decision Date 10/15/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No