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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K241311
Device Name Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
Applicant
Bernhard Förster GmbH
Westliche Karl-Friedrich-Strasse 151
75172
Pforzheim,  DE
Applicant Contact Stefan Förster
Correspondent
Bernhard Förster GmbH
Westliche Karl-Friedrich-Strasse 151
75172
Pforzheim,  DE
Correspondent Contact Stefan Förster
Classification Product Code
MQC  
Date Received05/09/2024
Decision Date 08/02/2024
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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