THERMOFORMED MOUTHGUARDS


Device Classification Name

mouthguard, prescription

510(k) Number K121365
Device Name THERMOFORMED MOUTHGUARDS
Applicant
GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP
2181 dupont dr.
irvine, 
CA 
92612

Applicant Contact armin zehtabchi
Correspondent
GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP
2181 dupont dr.
irvine, 
CA 
92612

Correspodent Contact armin zehtabchi
Classification Product Code
MQC  
Date Received 05/07/2012
Decision Date 11/20/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No