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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K162654
Device Name mollosil plus
Applicant
Detax GmbH & Co. KG
Carl-Zeiss-Str. 4
Ettlingen,  DE 76275
Applicant Contact Antje Reeps
Correspondent
Detax GmbH & Co. KG
Carl-Zeiss-Str. 4
Ettlingen,  DE 76275
Correspondent Contact Antje Reeps
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/23/2016
Decision Date 03/13/2017
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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