The following data is part of a premarket notification filed by Jj Medical Co., Ltd. with the FDA for Jplant.
| Device ID | K211978 |
| 510k Number | K211978 |
| Device Name: | Jplant |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJ Medical Co., Ltd. Daeryung Techno Town 3 409 Gasan-Dong, 115, Gasan Digital 2-Ro, Geumcheon-Gu Seoul, KR 08505 |
| Contact | Sun Jae Lee |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-25 |
| Decision Date | 2022-01-05 |