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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
Applicant
SPIDENT CO., LTD.
312, 151b-6l namdonggongdan
incheon, 
Contact i.s. whang
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/14/2012
Decision Date 05/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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