The following data is part of a premarket notification filed by Kj Meditech Co., Ltd with the FDA for Kj Zirconia Implant System.
| Device ID | K173116 |
| 510k Number | K173116 |
| Device Name: | KJ ZIRCONIA 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 | Hyukki Moon |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt 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 | 2017-09-29 |
| Decision Date | 2018-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809702406460 | K173116 | 000 |
| 08809702406187 | K173116 | 000 |
| 08809702406194 | K173116 | 000 |
| 08809702406200 | K173116 | 000 |
| 08809702406217 | K173116 | 000 |
| 08809702406224 | K173116 | 000 |
| 08809702406231 | K173116 | 000 |
| 08809702406248 | K173116 | 000 |
| 08809702406255 | K173116 | 000 |
| 08809702406170 | K173116 | 000 |
| 08809702406163 | K173116 | 000 |
| 08809702406088 | K173116 | 000 |
| 08809702406095 | K173116 | 000 |
| 08809702406101 | K173116 | 000 |
| 08809702406118 | K173116 | 000 |
| 08809702406125 | K173116 | 000 |
| 08809702406132 | K173116 | 000 |
| 08809702406149 | K173116 | 000 |
| 08809702406156 | K173116 | 000 |
| 08809702406262 | K173116 | 000 |
| 08809702406279 | K173116 | 000 |
| 08809702406385 | K173116 | 000 |
| 08809702406392 | K173116 | 000 |
| 08809702406408 | K173116 | 000 |
| 08809702406415 | K173116 | 000 |
| 08809702406422 | K173116 | 000 |
| 08809702406439 | K173116 | 000 |
| 08809702406446 | K173116 | 000 |
| 08809702406453 | K173116 | 000 |
| 08809702406378 | K173116 | 000 |
| 08809702406361 | K173116 | 000 |
| 08809702406286 | K173116 | 000 |
| 08809702406293 | K173116 | 000 |
| 08809702406309 | K173116 | 000 |
| 08809702406316 | K173116 | 000 |
| 08809702406323 | K173116 | 000 |
| 08809702406330 | K173116 | 000 |
| 08809702406347 | K173116 | 000 |
| 08809702406354 | K173116 | 000 |
| 08809702406071 | K173116 | 000 |