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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 K012827
Device Name PORTA AURIUM, MODEL 2067
Applicant
Wieland Edelmetalle GmbH & Co.
Schwenninger Strabe 13
Pforzheim,  DE D-75179
Applicant Contact GERHARD POLZER
Correspondent
Wieland Edelmetalle GmbH & Co.
Schwenninger Strabe 13
Pforzheim,  DE D-75179
Correspondent Contact GERHARD POLZER
Regulation Number872.3060
Classification Product Code
EJT  
Date Received08/23/2001
Decision Date 11/01/2001
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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