The following data is part of a premarket notification filed by Kj Meditech Co., Ltd. with the FDA for J2a Sla Dental Implant System.
| Device ID | K161923 |
| 510k Number | K161923 |
| Device Name: | J2A SLA Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | KJ Meditech Co., Ltd. 21, Cheomdan Venture-ro 40 Beon-gil, Buk-gu Gwangju, KR 500-470 |
| Contact | Goong-san Nam |
| 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 | 2016-07-13 |
| Decision Date | 2017-11-09 |
| Summary: | summary |