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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact ARMIN ZEHTABCHI
Classification Product Code
MQC  
Date Received05/07/2012
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
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