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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 K250456
Device Name Dentemp Pro-Comfort Dental Guard
Applicant
Doc Brands, Inc.
407 E. Lancaster Ave.
Wayne,  PA  19087
Applicant Contact Sean Stubbs
Correspondent
Doc Brands, Inc.
407 E. Lancaster Ave.
Wayne,  PA  19087
Correspondent Contact Eric Mowell
Classification Product Code
OBR  
Date Received02/18/2025
Decision Date 05/19/2025
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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