The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Midwest Rhino Xe And Air Motor M.
| Device ID | K192409 |
| 510k Number | K192409 |
| Device Name: | Midwest Rhino XE And Air Motor M |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Dentsply Sirona 221 W Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Karl Nittinger |
| Correspondent | Karl Nittinger Dentsply Sirona 221 W Philadelphia Street, Suite 60W York, PA 17401 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-01-13 |