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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 K180933
Device Name DenTek Ultimate Dental Guard
Applicant
Medtech Products, Inc.
660 White Plains Rd.
Suite 250
Tarrytown,  NY  10591
Applicant Contact Mary Beth Fritz
Correspondent
Prestige Brands Holdings
660 White Plains Rd.
Tarrytown,  NY  10591
Correspondent Contact Vincent Argiro
Classification Product Code
OBR  
Date Received04/10/2018
Decision Date 09/17/2018
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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