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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 K152215
Device Name DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
Applicant
Dentalplus GmbH
Kohlgrub 5
Samerberg,  DE 83122
Applicant Contact RALF GERSCHUETZ RUETH
Correspondent
Dentalplus GmbH
Kohlgrub 5
Samerberg,  DE 83122
Correspondent Contact RALF GERSCHUETZ RUETH
Regulation Number872.3770
Classification Product Code
EBG  
Date Received08/07/2015
Decision Date 01/19/2016
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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