Dental polishing cup, single-use [46938] (regulatory action (medical devices))
Product name
Dental polishing cup, single-use [46938]
Sponsor
ARTG
324066
Date action takes effect
Compliance action
Medical device cancellation
Type of action
regulatory action (medical devices)
Grounds for regulatory action
The device was incorrectly classified as a class I medical device. From the information available the device should be included on the ARTG at a higher classification. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect.