The following data is part of a premarket notification filed by Bioden Co., Ltd with the FDA for Zircos-com.
| Device ID | K190139 |
| 510k Number | K190139 |
| Device Name: | Zircos-Com |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Bioden Co., Ltd #B-803 119, Gasan Digital 1-ro, Geumcheon-gu Seoul, KR 08589 |
| Contact | Kim Hye Min |
| Correspondent | Chris Park Med.com 1809 Holland Dr Somerset, NJ 08873 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-29 |
| Decision Date | 2020-04-24 |