The following data is part of a premarket notification filed by Medimecca Co., Ltd. with the FDA for Honorst Implant System.
| Device ID | K202039 |
| 510k Number | K202039 |
| Device Name: | Honorst 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 08505 |
| Contact | Seung Yoon Lee |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-23 |
| Decision Date | 2020-09-25 |