The following data is part of a premarket notification filed by Kj Meditech Co., Ltd. with the FDA for J2i Implant System.
| Device ID | K140052 |
| 510k Number | K140052 |
| Device Name: | J2I IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | KJ MEDITECH CO., LTD. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung KJ MEDITECH CO., LTD. 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 | 2014-01-09 |
| Decision Date | 2014-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809488219797 | K140052 | 000 |
| 08809488219636 | K140052 | 000 |
| 08809488219629 | K140052 | 000 |
| 08809488219612 | K140052 | 000 |
| 08809488219605 | K140052 | 000 |
| 08809488219599 | K140052 | 000 |
| 08809488219582 | K140052 | 000 |
| 08809488219575 | K140052 | 000 |
| 08809488219568 | K140052 | 000 |
| 08809488219551 | K140052 | 000 |
| 08809488219544 | K140052 | 000 |
| 08809488219537 | K140052 | 000 |
| 08809488219520 | K140052 | 000 |
| 08809488219513 | K140052 | 000 |
| 08809488219643 | K140052 | 000 |
| 08809488219650 | K140052 | 000 |
| 08809488219780 | K140052 | 000 |
| 08809488219773 | K140052 | 000 |
| 08809488219766 | K140052 | 000 |
| 08809488219759 | K140052 | 000 |
| 08809488219742 | K140052 | 000 |
| 08809488219735 | K140052 | 000 |
| 08809488219728 | K140052 | 000 |
| 08809488219711 | K140052 | 000 |
| 08809488219704 | K140052 | 000 |
| 08809488219698 | K140052 | 000 |
| 08809488219681 | K140052 | 000 |
| 08809488219674 | K140052 | 000 |
| 08809488219667 | K140052 | 000 |
| 08809488219506 | K140052 | 000 |