| Primary Device ID | E27668127750 |
| NIH Device Record Key | b0d8dc6b-ec15-47e3-80fa-37b4b10db973 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Primescan 2 |
| Version Model Number | 6818699 |
| Company DUNS | 340306351 |
| Company Name | SIRONA Dental Systems GmbH |
| Device Count | 30 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| HIBCC | E27668127750 [Unit of Use] |
| HIBCC | E27668186992 [Primary] |
| NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-22 |
| Device Publish Date | 2024-03-14 |
| E27668310150 | 6831015 |
| E27668127750 | 6818699 |
| E27668356100 | Primescan 2 Spare |