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 |