| Primary Device ID | 08809488219735 |
| NIH Device Record Key | da3fb83d-0ecf-48db-88f6-75bbb6621a90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | J2I Implant System |
| Version Model Number | ISA6570 |
| Company DUNS | 688476027 |
| Company Name | KJMEDITECH.CO.,LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809488219735 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809488219735]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-19 |
| Device Publish Date | 2019-11-11 |
| 08809488219797 | J2I Implant System/Two Piece Abutment |
| 08809488219780 | J2I Implant System/Two Piece Abutment |
| 08809488219773 | J2I Implant System/Two Piece Abutment |
| 08809488219766 | J2I Implant System/Two Piece Abutment |
| 08809488219759 | J2I Implant System/Two Piece Abutment |
| 08809488219742 | J2I Implant System/Two Piece Abutment |
| 08809488219735 | J2I Implant System/Solid Abutment |
| 08809488219728 | J2I Implant System/Solid Abutment |
| 08809488219711 | J2I Implant System/Solid Abutment |
| 08809488219704 | J2I Implant System/Solid Abutment |
| 08809488219698 | J2I Implant System/Solid Abutment |
| 08809488219681 | J2I Implant System/Solid Abutment |
| 08809488219674 | J2I Implant System/Cover Screw |
| 08809488219667 | J2I Implant System/Cover Screw |
| 08809488219650 | J2I Implant System/Fixture |
| 08809488219643 | J2I Implant System/Fixture |
| 08809488219636 | J2I Implant System/Fixture |
| 08809488219629 | J2I Implant System/Fixture |
| 08809488219612 | J2I Implant System/Fixture |
| 08809488219605 | J2I Implant System/Fixture |
| 08809488219599 | J2I Implant System/Fixture |
| 08809488219582 | J2I Implant System/Fixture |
| 08809488219575 | J2I Implant System/Fixture |
| 08809488219568 | J2I Implant System/Fixture |
| 08809488219551 | J2I Implant System/Fixture |
| 08809488219544 | J2I Implant System/Fixture |
| 08809488219537 | J2I Implant System/Fixture |
| 08809488219520 | J2I Implant System/Fixture |
| 08809488219513 | J2I Implant System/Fixture |
| 08809488219506 | J2I Implant System/Fixture |