The following data is part of a premarket notification filed by Izenimplant Co., Ltd. with the FDA for Zenex Implant System.
Device ID | K211090 |
510k Number | K211090 |
Device Name: | ZENEX Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | Izenimplant Co., Ltd. 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon Pyeongtaek-si, KR 17703 |
Contact | Mi-kyung Kwon |
Correspondent | Milly Milly KMC, Inc. Room No. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, KR 08390 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-12 |
Decision Date | 2022-04-13 |