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 |