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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 K211415
Device Name GR Splint Resin System
Applicant
Pro3dure Medical GmbH
Am Burgberg 13
Iserlohn,  DE 58642
Applicant Contact Frank Gischer
Correspondent
Regulatory and Quality Solutions, LLC
2790 Mosside Blvd.
Pittsburgh,  PA  15146
Correspondent Contact Patricia Kontoudis
Classification Product Code
MQC  
Subsequent Product Codes
EBI   KMY  
Date Received05/06/2021
Decision Date 10/21/2021
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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