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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K120767
Device Name ES BOND
Applicant
SPIDENT CO., LTD.
312, 151B-6L NAMDONGGONGDAN
INCHEON,  KR 405-821
Applicant Contact I.S. WHANG
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number872.3200
Classification Product Code
KLE  
Date Received03/14/2012
Decision Date 05/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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