The following data is part of a premarket notification filed by Dentkist, Inc. with the FDA for Charmfil.
| Device ID | K193496 |
| 510k Number | K193496 |
| Device Name: | CharmFil |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Dentkist, Inc. 3, Nongshim-ro Gunpo-si, KR 15842 |
| Contact | Shin Haeng Lee |
| Correspondent | Peter Chung Plus Global 300 Atwood St. Pittsburgh, PA 15213 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-05-06 |