510(k) K172952

Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit by Figaro Crowns, Inc. — Product Code EBF

K172952 is an FDA 510(k) premarket notification submitted by Figaro Crowns, Inc. for the device "Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit". The FDA issued a decision of Substantially Equivalent on Jul 3, 2018. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 3, 2018
Date Received
Sep 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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