Hon. Anne McLellan (Minister of Health, Lib.)
(c) Health Canada does not test any dental restorative materials, including dental plastics. Dental plastics are regulated as a medical device in Canada. The manufacturer of these products must provide evidence that the material satisfies the safety and effectiveness requirements of the Food and Drugs Act and the medical devices regulations before it may be legally sold in Canada. The medical devices regulations also require the reporting of adverse events or incidents causing injury to users of medical devices.
(d) There is no Health Canada licence for a dental device named Conquest. Dental restorative materials, such as those that contain BPA, are class III devices. The medical devices regulations require manufacturers of class III devices to provide evidence of safety and effectiveness before being authorized to sell. Manufacturers are obliged to inform the regulator should evidence to the contrary come to light. Health Canada has found no test results or other evidence suggesting that Conquest or other dental restorative materials containing BPA are unsafe.
(e) One inquiry has been made on behalf of an alleged victim.
(g) Health Canada is not aware of other jurisdictions that restrict the use of dental plastic containing BPA.
Subtopic: Question No. 211