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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 K034049
Device Name HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
Applicant
Heraeus Kulzer,GmbH
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
Heraeus Kulzer,GmbH
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3060
Classification Product Code
EJT  
Subsequent Product Code
EJS  
Date Received12/30/2003
Decision Date 03/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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