The following data is part of a premarket notification filed by Adamant Co., Ltd. with the FDA for Adamant Zirconia Disc.
| Device ID | K160203 |
| 510k Number | K160203 |
| Device Name: | ADAMANT ZIRCONIA DISC |
| Classification | Powder, Porcelain |
| Applicant | Adamant Co., Ltd. 1-16-7 Shinden, Adachi Ku Tokyo, JP 123-8595 |
| Contact | Deborah Lavoie Grayeski |
| Correspondent | Deborah Lavoie Grayeski M Squared Associates 575 Eighth Ave, Suite 1212 New York, NY 10018 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-28 |
| Decision Date | 2016-10-19 |
| Summary: | summary |