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510(k) K183476

3M Filtek Universal Restorative by 3M Espe Dental Products — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2019
Date Received
December 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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