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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 K090472
Device Name GRIND GUARD
Applicant
ARCHTEK, INC.
1705 SOUTH CAPITOL OF TEXAS HW
AUSTIN,  TX  78746
Applicant Contact KRISTA OAKES
Correspondent
ARCHTEK, INC.
1705 SOUTH CAPITOL OF TEXAS HW
AUSTIN,  TX  78746
Correspondent Contact KRISTA OAKES
Classification Product Code
MQC  
Date Received02/24/2009
Decision Date 10/14/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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