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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 K212017
Device Name Thermeo System
Applicant
Pro3dure Medical GmbH
Am Burgberg 13
Iserlohn,  DE 58642
Applicant Contact Frank Gischer
Correspondent
Pro3dure Medical GmbH
Am Burgberg 13
Iserlohn,  DE 58642
Correspondent Contact Frank Gischer
Classification Product Code
MQC  
Date Received06/28/2021
Decision Date 04/08/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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