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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K023389
Device Name PORTA GEO TI
Applicant
Wieland Dental + Technik GmbH & Co. KG
Schwenninger Strasse 13
Pforzheim,  DE D75179
Applicant Contact RUDOLF WAGNER
Correspondent
Wieland Dental + Technik GmbH & Co. KG
Schwenninger Strasse 13
Pforzheim,  DE D75179
Correspondent Contact RUDOLF WAGNER
Regulation Number872.3060
Classification Product Code
EJT  
Date Received10/09/2002
Decision Date 12/06/2002
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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