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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 K152471
Device Name CAPO BULK FILL
Applicant
Schuetz Dental GmbH
Dieselstr. 5-6
Rosbach,  DE 61191
Applicant Contact Anke Puent
Correspondent
Schuetz Dental GmbH
Dieselstr. 5-6
Rosbach,  DE 61191
Correspondent Contact Anke Puent
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/31/2015
Decision Date 08/04/2016
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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