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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 K123397
Device Name MULTILINK AUTOMIX
Applicant
Ivoclar Vivadent, AG
Bendererstrasse 2
Schaan,  LI FL-9494
Applicant Contact SANDRA CAKEBREAD
Correspondent
Ivoclar Vivadent, AG
Bendererstrasse 2
Schaan,  LI FL-9494
Correspondent Contact SANDRA CAKEBREAD
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/05/2012
Decision Date 01/31/2013
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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