| Primary Device ID | E27667483590 |
| NIH Device Record Key | c0b1f4da-4fee-4ad6-a611-5be07e15d322 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CEREC Ortho Software |
| Version Model Number | 6748359 |
| Company DUNS | 340306351 |
| Company Name | SIRONA Dental Systems GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E27667483590 [Primary] |
| PNN | Orthodontic Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-18 |
| Device Publish Date | 2021-05-10 |
| E27666979860 | CEREC Ortho Software Version 2.0.0 |
| E27666111690 | CEREC Ortho Software Version 1.2.0 |
| E27667483590 | CEREC Ortho Software Version 2.1 |
| E27667844950 | CEREC Ortho Software Version 2.1 Upgrade |