| Primary Device ID | 08800341412423 |
| NIH Device Record Key | 58185e89-92b1-44b8-9d63-0b742593fffb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Solution Kit |
| Version Model Number | SOK-SET |
| Company DUNS | 557821945 |
| Company Name | ARUM DENTISTRY Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800341412423 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800341412423]
Moist Heat or Steam Sterilization
[08800341412423]
Moist Heat or Steam Sterilization
[08800341412423]
Moist Heat or Steam Sterilization
[08800341412423]
Moist Heat or Steam Sterilization
[08800341412423]
Moist Heat or Steam Sterilization
[08800341412423]
Moist Heat or Steam Sterilization
[08800341412423]
Moist Heat or Steam Sterilization
[08800341412423]
Moist Heat or Steam Sterilization
[08800341412423]
Moist Heat or Steam Sterilization
[08800341412423]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-04-01 |
| Device Publish Date | 2026-03-24 |
| 08800055791203 - NB Master Kit | 2026-04-01 |
| 08800055791210 - NB Regular Kit | 2026-04-01 |
| 08800055792774 - Fixture Driver Machine | 2026-04-01 |
| 08800055792781 - Fixture Driver Machine | 2026-04-01 |
| 08800055792798 - Fixture Driver Machine | 2026-04-01 |
| 08800055792804 - Fixture Driver Machine | 2026-04-01 |
| 08800055792910 - Torque Extension | 2026-04-01 |
| 08800055792958 - Trial Pin | 2026-04-01 |