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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K200039
Device Name P pro Crown & Bridge
Applicant
DeltaMed GmbH
Raiffeisenstrasse 8a
Friedberg,  DE 61169
Applicant Contact Michael Zimmerman
Correspondent
Cosmedent, Inc
401 N Michigan Ave, Suite 2500
Chicago,  IL  60611
Correspondent Contact Gary Chuven
Regulation Number872.3770
Classification Product Code
EBG  
Date Received01/08/2020
Decision Date 07/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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