The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for W&h Assistina Twin.
| Device ID | K171553 |
| 510k Number | K171553 |
| Device Name: | W&H Assistina Twin |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | W & H Dentalwerk Buermoos GmbH Ignaz-Glaser-StraBe 53 Buermoos, AT 5111 |
| Contact | Mag. Anja Lindner |
| Correspondent | Mag. Anja Lindner W & H Dentalwerk Buermoos GmbH Ignaz-Glaser-StraBe 53 Buermoos, 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 | 2017-05-30 |
| Decision Date | 2017-12-08 |
| Summary: | summary |