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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 K202974
Device Name DenTek Fresh Protect Dental Guard
Applicant
Medtech Products, Inc.
660 White Plains Rd.
Tarrytown,  NY  10591
Applicant Contact Vincent Argiro
Correspondent
Medtech Products, Inc.
660 White Plains Rd.
Tarrytown,  NY  10591
Correspondent Contact Vincent Argiro
Classification Product Code
OBR  
Date Received09/30/2020
Decision Date 12/22/2020
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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