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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, tooth shade, resin
510(k) Number K120768
Device Name ES FLOW
Original Applicant
SPIDENT CO., LTD.
312, 151b-6l namdonggongdan
incheon,  KR 405-821
Original Contact i.s. whang
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/14/2012
Decision Date 05/03/2012
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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