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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K233064
Device Name Copra Supreme
Applicant
Whitepeaks Dental Solutions GmbH
Alfredstrasse 81
Essen,  DE 45130
Applicant Contact Oliver Puckert
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030 -0172
Correspondent Contact Angela Blackwell
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/26/2023
Decision Date 09/18/2024
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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