The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Piezomed.
| Device ID | K133488 |
| 510k Number | K133488 |
| Device Name: | PIEZOMED |
| Classification | Drill, Bone, Powered |
| Applicant | W & H DENTALWERK BUERMOOS GMBH IGNAZ-GLASER-STRASSE 53 Buermoos, Salzburg, AT 5111 |
| Contact | Anja Lindner |
| Correspondent | Anja Lindner W & H DENTALWERK BUERMOOS GMBH IGNAZ-GLASER-STRASSE 53 Buermoos, Salzburg, AT 5111 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-13 |
| Decision Date | 2014-10-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PIEZOMED 79124023 4430612 Live/Registered |
W & H Deutschland GmbH 2012-12-06 |