The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Advanced Air System.
| Device ID | K143704 |
| 510k Number | K143704 |
| Device Name: | Advanced Air System |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | W & H Dentalwerk Buermoos GmbH Ignaz-Glaser-Strasse 53 Buermoos, AT 5111 |
| Contact | Anja Lindner |
| Correspondent | Mag. Anja Lindner W & H Dentalwerk Buermoos GmbH Ignaz-Glaser-Strasse 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 | 2014-12-29 |
| Decision Date | 2015-11-23 |
| Summary: | summary |