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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 K022451
Device Name AUROPAL SOLDER W-2
Applicant
WIELAND DENTAL + TECHNIK GMBH & CO. KG
SCHWENNINGER STRASSE 13
pforzheim,  DE d 75179
Applicant Contact gerhard polzer
Correspondent
WIELAND DENTAL + TECHNIK GMBH & CO. KG
SCHWENNINGER STRASSE 13
pforzheim,  DE d 75179
Correspondent Contact gerhard polzer
Regulation Number872.3060
Classification Product Code
EJT  
Date Received07/26/2002
Decision Date 09/11/2002
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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