The following data is part of a premarket notification filed by W&h Dentalwerk Buermoos Gmbh with the FDA for Electric Handpiece Motor.
| Device ID | K181858 |
| 510k Number | K181858 |
| Device Name: | Electric Handpiece Motor |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | W&H Dentalwerk Buermoos GmbH Ignaz-Glaser-Strasse 53 Burmoos, AT 5111 |
| Contact | Anja Lindner |
| Correspondent | Anja Lindner W&H Dentalwerk Buermoos GmbH Ignaz-Glaser-Strasse 53 Burmoos, AT 5111 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2019-03-26 |
| Summary: | summary |