The following data is part of a premarket notification filed by Bioden Co., Ltd with the FDA for Non-sterile Zirconia Block.
| Device ID | K201492 |
| 510k Number | K201492 |
| Device Name: | Non-Sterile Zirconia Block |
| Classification | Powder, Porcelain |
| Applicant | Bioden Co., Ltd #B-803 119, Gasan Digital 1-ro, Geumcheon-gu, Korea Seoul, KR |
| Contact | Myeongeun Song |
| Correspondent | Chris Park Med.com 1809 Holland Dr Somerset, NJ 08873 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-04 |
| Decision Date | 2021-03-10 |