The following data is part of a premarket notification filed by Kj Meditech Co., Ltd. with the FDA for Kj Mini Implant System.
| Device ID | K151970 |
| 510k Number | K151970 |
| Device Name: | KJ Mini Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | KJ MEDITECH CO., LTD. 959-21 DAECHON-DONG, BUK-GU Gwang-ju, KR 959-21 |
| Contact | Goong-san Nam |
| Correspondent | Priscilla Chung LK CONSULTING GROUP USA, INC. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-16 |
| Decision Date | 2016-10-21 |
| Summary: | summary |