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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 K033435
Device Name E-SARANG 86, DM78, DM55
Applicant
We Dong Myung Dental Industrial Co., Ltd.
1733 Canton Ln.
Marietta,  GA  30062
Applicant Contact RONALD D ARKIN
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number872.3060
Classification Product Code
EJT  
Date Received10/28/2003
Decision Date 11/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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