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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 K022462
Device Name BIOPORTA SOLDER 1020
Applicant
Wieland Dental + Technik GmbH & Co. KG
Schwenninger Strasse 13
Pforzheim,  DE D75179
Applicant Contact GERHARD POLZER
Correspondent
Wieland Dental + Technik GmbH & Co. KG
Schwenninger Strasse 13
Pforzheim,  DE D75179
Correspondent Contact GERHARD POLZER
Regulation Number872.3060
Classification Product Code
EJT  
Date Received07/26/2002
Decision Date 09/18/2002
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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