| Primary Device ID | 06973993442543 |
| NIH Device Record Key | 9ed8b7a4-6c62-4fc3-a673-4ef660c1c29b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straumann SIRIOS X3 |
| Version Model Number | ST 300E |
| Catalog Number | STS-6583514-E |
| Company DUNS | 703541803 |
| Company Name | Alliedstar Medical Equipment Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06973993442543 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
[06973993442543]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-22 |
| Device Publish Date | 2025-08-14 |
| 06973993442840 | Straumann SIRIOS™ X3 Intraoral scanner Hardware As A Service |
| 06973993442543 | Straumann SIRIOS™ X3 Intraoral scanner Education |
| 06973993442451 | Straumann SIRIOS™ X3 Intraoral scanner |
| 06973993442444 | Straumann SIRIOS™ X3 Intraoral scanner Demo |
| 06973993441751 | Straumann SIRIOS™ X3 Intraoral scanner Charging Holder |
| 06973993440303 | Straumann SIRIOS™ X3 Intraoral scanner Handpiece |
| 06973993441737 | Straumann SIRIOS™ X3 Intraoral scanner Tip (2pcs) |