The following data is part of a premarket notification filed by Medimecca Co., Ltd. with the FDA for Chaorum Implant System.
| Device ID | K160536 |
| 510k Number | K160536 |
| Device Name: | Chaorum Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEDIMECCA CO., LTD. DAERYUNG TECHNO TOWN 3-CHA 104, 105, 109, 110, GASAN-DONG,115 Seoul, KR 153-772 |
| Contact | Park Young Wan |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 ROOSEVELT STE 417 Irvine, CA 92606 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-26 |
| Decision Date | 2017-01-05 |
| Summary: | summary |