The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Midwest Rdh Freedom Cordless Prophy System.
| Device ID | K110753 |
| 510k Number | K110753 |
| Device Name: | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. 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 | 2011-03-18 |
| Decision Date | 2011-06-06 |
| Summary: | summary |