| Primary Device ID | 06970873260389 |
| NIH Device Record Key | eb99b5e7-8b28-4da2-a4bd-d1b01fb7a322 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integrated Endo System |
| Version Model Number | Meet Endo-II |
| Company DUNS | 529329650 |
| Company Name | DENJOY DENTAL 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 06970873260389 [Primary] |
| GS1 | 16970873260386 [Package] Package: [4 Units] In Commercial Distribution |
| EKR | Plugger, Root Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06970873260389]
Dry Heat Sterilization
[06970873260389]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-10 |
| Device Publish Date | 2025-02-28 |
| 06970873260389 - Integrated Endo System | 2025-03-10 |
| 06970873260389 - Integrated Endo System | 2025-03-10 |
| 06970873260013 - PULP TESTER | 2022-02-28 |
| 06970873260051 - Endo Motor | 2022-02-28 |
| 06970873260068 - Endo Motor | 2022-02-28 |
| 06970873260075 - Endo Motor | 2022-02-28 |
| 06970873260082 - Cordless Gutta percha obturation system | 2022-02-28 |
| 06970873260112 - Endo Rotary file | 2022-02-28 K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH |
| 06970873260143 - Gutta percha obturation system | 2022-02-28 |