The following data is part of a premarket notification filed by Figaro Crowns, Inc. with the FDA for Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit.
Device ID | K172952 |
510k Number | K172952 |
Device Name: | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit |
Classification | Material, Tooth Shade, Resin |
Applicant | Figaro Crowns, Inc. 1628 Quail Ridge Circle Woodbury, MN 55125 |
Contact | Kyle Rose |
Correspondent | Kyle Rose Figaro Crowns, Inc. 1628 Quail Ridge Circle Woodbury, MN 55125 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-26 |
Decision Date | 2018-07-03 |
Summary: | summary |