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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 K150492
Device Name Ora-GUARD Dental Grind Guard
Applicant
Bite Tech, Inc.
20 Glover Ave.
Norwalk,  CT  06850
Applicant Contact Jeff Padovan
Correspondent
Hyman, Phelps & McNamara, P.C.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Correspondent Contact Alex Varond
Classification Product Code
OBR  
Date Received02/25/2015
Decision Date 02/19/2016
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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