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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
Device Name PROTECH DENT
Applicant
Akervall Technologies, Inc.
5520 Stone Valley Dr.
Ann Arbor,  MI  48105
Applicant Contact SASSA AKERVALL
Correspondent
Akervall Technologies, Inc.
5520 Stone Valley Dr.
Ann Arbor,  MI  48105
Correspondent Contact SASSA AKERVALL
Classification Product Code
OBR  
Date Received04/27/2012
Decision Date 10/15/2012
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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