The following data is part of a premarket notification filed by W&h Dentalwerk Buermoos Gmbh with the FDA for Proxeo Twist Cordless Polishing System Pl-40 H.
| Device ID | K201703 |
| 510k Number | K201703 |
| Device Name: | PROXEO Twist Cordless Polishing System PL-40 H |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | W&H Dentalwerk Buermoos GmbH Ignaz Glaser Strasse 53 Buermoos, AT At - 5111 |
| Contact | Johann Georg Scharl |
| Correspondent | Johann Georg Scharl W&H Dentalwerk Buermoos GmbH Ignaz Glaser Strasse 53 Buermoos, AT At - 5111 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2021-02-24 |