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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 K120453
Device Name FILTEK BULK FILL FLOWABLE RESTORATIVE
Original Applicant
3M ESPE DENTAL PRODUCTS
3m center; bldg 260-2a-11
st. paul,  MN  55144 -1000
Original Contact scott erickson
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/14/2012
Decision Date 03/19/2012
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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