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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
Predetermined Change
Control Plan Authorized		 No
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