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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 K012839
Device Name AUROPAL, ORDER-NO.: 2101
Applicant
WIELAND EDELMETALLE GMBH & CO.
SCHWENNINGER STRABE 13
D-75179 PFORZHEIM,  DE
Applicant Contact GERHARD P0LZER
Correspondent
WIELAND EDELMETALLE GMBH & CO.
SCHWENNINGER STRABE 13
D-75179 PFORZHEIM,  DE
Correspondent Contact GERHARD P0LZER
Regulation Number872.3060
Classification Product Code
EJT  
Date Received08/23/2001
Decision Date 12/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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