The following data is part of a premarket notification filed by Shinhung Mst Co., Ltd. with the FDA for Magden Dental Implant System.
| Device ID | K162867 |
| 510k Number | K162867 |
| Device Name: | MagDen Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SHINHUNG MST Co., Ltd. 110-2, Donghwagongdan-ro Munmak-eup Wonju-si, KR 220-801 |
| Contact | Lee Sunbyung |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt STE 417 Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-13 |
| Decision Date | 2017-07-26 |
| Summary: | summary |