| Primary Device ID | E27668665320 |
| NIH Device Record Key | c24521ca-f7f3-4269-8cf8-02456a4629a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Midwest IMPLANT 20:1 |
| Version Model Number | 6866532 |
| 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 |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E27668665320 [Primary] |
| EKX | Handpiece, direct drive, ac-powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E27668665320]
Moist Heat or Steam Sterilization
[E27668665320]
Moist Heat or Steam Sterilization
[E27668665320]
Moist Heat or Steam Sterilization
[E27668665320]
Moist Heat or Steam Sterilization
[E27668665320]
Moist Heat or Steam Sterilization
[E27668665320]
Moist Heat or Steam Sterilization
[E27668665320]
Moist Heat or Steam Sterilization
[E27668665320]
Moist Heat or Steam Sterilization
[E27668665320]
Moist Heat or Steam Sterilization
[E27668665320]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-27 |
| Device Publish Date | 2026-02-19 |
| E27668665320 - Midwest IMPLANT 20:1 | 2026-02-27Midwest IMPLANT 20:1 |
| E27668665320 - Midwest IMPLANT 20:1 | 2026-02-27 Midwest IMPLANT 20:1 |
| E27668312130 - Midwest Motor Control Module | 2026-02-25 Midwest Motor Control Module |
| E27668234260 - Primevision 3D | 2026-02-23 Primevision 3D |
| E27668302980 - Midwest Power Lux Implant Motor | 2026-02-23 Midwest Power Lux Implant Motor |
| E27668303060 - Midwest Power Lux Motor | 2026-02-23 Midwest Power Lux Motor |
| E27665716860 - SiroLaser | 2025-09-11 single-use tips pack 250 |
| E27662122080 - Motor BL implant | 2025-08-28 Motor BL implant |
| E27668534800 - CAD/CAM Software | 2025-08-27 CEREC SW 5.2 Full version, Primary, EDU |