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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K211804
Device Name 3Delta Crown
Applicant
Deltamed GmbH
Raiffeisenstrasse 8a
Friedberg,  DE 61169
Applicant Contact Michael Zimmermann
Correspondent
Cosmedent, Inc.
401 N. Michigan Ave. Suite 2500
Chicago,  IL  60611
Correspondent Contact Gary Chuven
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/11/2021
Decision Date 12/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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