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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 K033279
Device Name GOLD DENTAL CASTING ALLOYS
Applicant
Bego U.S.A.
24 Albion Rd. Suite 103
Lincoln,  RI  02865
Applicant Contact WILLIAM OREMUS
Correspondent
Bego U.S.A.
24 Albion Rd. Suite 103
Lincoln,  RI  02865
Correspondent Contact WILLIAM OREMUS
Regulation Number872.3060
Classification Product Code
EJT  
Date Received10/10/2003
Decision Date 01/15/2004
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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