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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 K032106
Device Name STARBOND DENTAL BONDING ALLOYS
Applicant
Star Refining Precious Metals South Africa
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED E DEVINE
Regulation Number872.3060
Classification Product Code
EJT  
Subsequent Product Code
EJS  
Date Received07/08/2003
Decision Date 08/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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