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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 K012835
Device Name PORTA MAXIMUM, MODEL# 2066
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
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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