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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 K151399
Device Name Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
Applicant
Schutz Dental GmbH
Dieselstrasse 5-6
Rosbach,  DE DE 61191
Applicant Contact ANTJE MAURER
Correspondent
Schutz Dental GmbH
Dieselstrasse 5-6
Rosbach,  DE DE 61191
Correspondent Contact ANTJE MAURER
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/26/2015
Decision Date 10/24/2016
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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