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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K103773
Device Name ZENOFLEX DIMENSION
Applicant
Wieland Dental + Technik GmbH & Co. KG
Schwenninger Strabe 13
Pforzheim,  DE D-75179
Applicant Contact GERHARD POLZER
Correspondent
Wieland Dental + Technik GmbH & Co. KG
Schwenninger Strabe 13
Pforzheim,  DE D-75179
Correspondent Contact GERHARD POLZER
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/27/2010
Decision Date 03/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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