The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Midwest Rdh Freedom Cordless Prophy System With Smartmode Technology.
| Device ID | K160825 |
| 510k Number | K160825 |
| Device Name: | MIDWEST RDH Freedom Cordless Prophy System With SmartMode Technology |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | DENTSPLY SIRONA 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY SIRONA 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-25 |
| Decision Date | 2016-09-27 |
| Summary: | summary |