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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 K191836
Device Name Ceramill A-Splint
Amann Girrbach AG
Herrschaftswiesen 1
Koblach,  AT 6842
Applicant Contact Debora Engel
Emergo Europe Consulting
Prinsessegracht 20
The Hague,  NL 2514AP
Correspondent Contact Rachel Paul
Classification Product Code
Date Received07/09/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No