| Primary Device ID | 08800055792781 |
| NIH Device Record Key | 453da2de-0f57-4d9e-8577-0b317e7e280c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fixture Driver Machine |
| Version Model Number | FDM31M |
| 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 | 08800055792781 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800055792781]
Moist Heat or Steam Sterilization
[08800055792781]
Moist Heat or Steam Sterilization
[08800055792781]
Moist Heat or Steam Sterilization
[08800055792781]
Moist Heat or Steam Sterilization
[08800055792781]
Moist Heat or Steam Sterilization
[08800055792781]
Moist Heat or Steam Sterilization
[08800055792781]
Moist Heat or Steam Sterilization
[08800055792781]
Moist Heat or Steam Sterilization
[08800055792781]
Moist Heat or Steam Sterilization
[08800055792781]
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 |
| 08800341413826 | TFDM37R |
| 08800341413819 | TFDM33R |
| 08800341413802 | TFDM27R |
| 08809982755876 | FDM33R |
| 08809982755869 | FDM27R |
| 08809982755852 | FDM32M |
| 08800293191667 | FDM37R |
| 08800293191650 | FDM37M |
| 08800055792804 | FDM32R |
| 08800055792798 | FDM26R |
| 08800055792781 | FDM31M |
| 08800055792774 | FDM25M |