The following data is part of a premarket notification filed by W&h Dentalwerk Burmoos Gmbh with the FDA for Air-powered Handpieces And Handpiece Attachments.
| Device ID | K162926 |
| 510k Number | K162926 |
| Device Name: | Air-Powered Handpieces And Handpiece Attachments |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | W&H DENTALWERK BURMOOS GMBH IGNAZ-GLASER-STRABE 53 Bürmoos, AT 5111 |
| Contact | Anja Lindner |
| Correspondent | Anja Lindner W&H DENTALWERK BURMOOS GMBH IGNAZ-GLASER-STRABE 53 Bürmoos, AT 5111 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-19 |
| Decision Date | 2017-02-23 |
| Summary: | summary |