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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 K112868
Device Name DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
Applicant
Dreamgard, Inc.
1601 K St. NW
Washington,  DC  20006
Applicant Contact SUZAN ONEL
Correspondent
Dreamgard, Inc.
1601 K St. NW
Washington,  DC  20006
Correspondent Contact SUZAN ONEL
Classification Product Code
MQC  
Date Received09/30/2011
Decision Date 01/19/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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