| Primary Device ID | 08800293194873 |
| NIH Device Record Key | 66325551-87f8-41fa-b622-8fbd28488e24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sinus Drill Stopper |
| Version Model Number | SDS3 |
| 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 | 08800293194873 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800293194873]
Moist Heat or Steam Sterilization
[08800293194873]
Moist Heat or Steam Sterilization
[08800293194873]
Moist Heat or Steam Sterilization
[08800293194873]
Moist Heat or Steam Sterilization
[08800293194873]
Moist Heat or Steam Sterilization
[08800293194873]
Moist Heat or Steam Sterilization
[08800293194873]
Moist Heat or Steam Sterilization
[08800293194873]
Moist Heat or Steam Sterilization
[08800293194873]
Moist Heat or Steam Sterilization
[08800293194873]
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 |
| 08800293196440 | SDS115 |
| 08800293196433 | SDS85 |
| 08800293196426 | SDS55 |
| 08800293196419 | SDS10 |
| 08800293194927 | SDS8 |
| 08800293194910 | SDS7 |
| 08800293194903 | SDS6 |
| 08800293194897 | SDS5 |
| 08800293194880 | SDS4 |
| 08800293194873 | SDS3 |