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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 K200125
Device Name Thermoforming Sheet Materials
Applicant
Erkodent Erich Kopp GmbH
Siemensstrasse 3
Pfalzgrafenweiler,  DE 72285
Applicant Contact Hans-Peter Kopp
Correspondent
AJW Technology Consultants, Inc.
11705 Boyette Road, Suite 503
Riverview,  FL  33569
Correspondent Contact Jon Ward
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received01/21/2020
Decision Date 10/28/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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