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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 K915507
Device Name E-Z GOLD TOOTH FILLING MATERIAL
Applicant
Lloyd Baum Center, Inc.
25742 Hinckley St.
Loma Linda,  CA  92354
Applicant Contact LLOYD BAUM
Correspondent
Lloyd Baum Center, Inc.
25742 Hinckley St.
Loma Linda,  CA  92354
Correspondent Contact LLOYD BAUM
Regulation Number872.3060
Classification Product Code
EJT  
Date Received12/09/1991
Decision Date 05/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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