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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 K131664
Device Name COPRA TEMP PMMA-DISK
Applicant
White Peaks Dental Systems GmbH & Co. KG
361 Farmington Ave.
Louisville,  KY  40217
Applicant Contact JOHN WATERS
Correspondent
White Peaks Dental Systems GmbH & Co. KG
361 Farmington Ave.
Louisville,  KY  40217
Correspondent Contact JOHN WATERS
Regulation Number872.3770
Classification Product Code
EBG  
Date Received06/07/2013
Decision Date 12/18/2013
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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