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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 K080182
Device Name ZENO PMMA DISC
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 Number872.3770
Classification Product Code
EBG  
Date Received01/25/2008
Decision Date 04/08/2008
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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