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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mouthguard, over-the-counter
510(k) Number K121272
Models ITD-1, ITD-2, PTD-1(ADUIT), PTD-2(CHILD)
Device Name PROTECH DENT
Original Applicant
AKERVALL TECHNOLOGIES INC
5520 stone valley drive
ann arbor,  MI  48105
Original Contact sassa akervall
Classification Product Code
OBR  
Date Received04/27/2012
Decision Date 10/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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