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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 K012838
Device Name ERO50, ORDER-NO.: 2070
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 10/23/2001
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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