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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 K260031
Device Name THERMEO® I MSI
Applicant
Pro3Dure Medical GmbH
Am Burgberg 13
Iserlohn,  DE 58642
Applicant Contact Frank Gischer
Correspondent
Kontoudis Consulting, LLC
804 Umbra St.
Baltimore,  MD  21224
Correspondent Contact Patricia Kontoudis
Classification Product Code
MQC  
Date Received01/06/2026
Decision Date 09/29/2026
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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