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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 K183476
Device Name 3M Filtek Universal Restorative
Applicant
3M ESPE Dental Products
2510 Conway Ave.
st. paul,  MN  55144
Applicant Contact lam duong
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25TH STREET, NW
buffalo,  MN  55313
Correspondent Contact mark job
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/17/2018
Decision Date 01/02/2019
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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