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 |