Gauge, depth, dental implant (Cancelled under s.41GN(1)(f))
Product name
Gauge, depth, dental implant
Sponsor
ARTG
202502
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled under s.41GN(1)(f)
Grounds for regulatory action
As the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certification made under s.41FD (f) and (g) were incorrect.
A review under s.60 of the Act upheld the initial decision to cancel the device from the Register.