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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Other Noble Metal
510(k) Number K012828
Device Name PORTA SMK 82, MODEL 2032
Applicant
Wieland Edelmetalle GmbH & Co.
Schwenninger Strabe 13
D-75179 Pforzheim,  DE
Applicant Contact GERHARD POLZER
Correspondent
Wieland Edelmetalle GmbH & Co.
Schwenninger Strabe 13
D-75179 Pforzheim,  DE
Correspondent Contact GERHARD POLZER
Regulation Number872.3060
Classification Product Code
EJS  
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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