| Primary Device ID | E27665918580 |
| NIH Device Record Key | 5b7f14f1-d8cd-48d5-be13-9d6d9bf98c7c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTEGO pro TS ambidextrous with disinfection |
| Version Model Number | 6591858 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E27665918580 [Primary] |
| EIA | Unit, Operative Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-10 |
| E27668053650 - Primescan 2 Multiuse Sleeve | 2025-05-14 Primescan 2 Multiuse Sleeve |
| E27668325750 - TiBase | 2025-05-14 TiBase AT EV 3.0 GH2 S |
| E27668325830 - TiBase | 2025-05-14 TiBase AT EV 3.6 GH2 S |
| E27668326090 - TiBase | 2025-05-14 TiBase AT EV 4.8 GH2 L |
| E27668326170 - TiBase | 2025-05-14 TiBase AT EV 5.4 GH2 L |
| E27668326250 - TiBase | 2025-05-14 TiBase AT EV 3.0 GH3 S |
| E27668326330 - TiBase | 2025-05-14 TiBase AT EV 3.6 GH3 S |
| E27668326580 - TiBase | 2025-05-14 TiBase AT EV 4.8 GH3 L |