Is this Orthodontic Retainer Component a Medical Device in Canada?

R

romeotang

#1
Hello,

I am having a hard time determining whether the product I will be manufacturing is a medical device in Canada.

The product is a component that will be adapted onto other components and materials (steel wires and polymerized acrylic) to form a custom made orthodontic retainer. Our component is then customized by the dental technician to form the patient's dental arch for tooth stabilization according to the prescription made by the dental professional. This orthodontic appliance is then sent to the orthodontist or dentist for the patient to use.

I am aware of rules 1,2 and 3 on schedule 1 section 6 in the classification rules for medical devices on the Health Canada website.

I am curious to know if you think this component is a medical device, if so why?

Thank you,

Jason
 
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R

romeotang

#4
Hi DannyK,

Thanks for getting back to me, much appreciated.
The component we will be supplying is not an orthodontic retainer. It's a component that needs to be adapted and customized by the orthodontic technician (The buyer of our component) to meet the specific requirements of the dental professional.

Once adapted with the rest of the components, it forms a customized orthodontic retainer for the patient. This orthodontic retainer is sent from the laboratory to the dental professional's office.

After seeing that this device is not subject to the MDD regulation, I was wondering why it would be for Health Canada's regulations.

I found this link (Refer to the second question)
www. gdc- uk. org/Newsandpublications/Publications/Publications/standards dentalappFAQMay10.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

Thanks!
Jason
 
Last edited by a moderator:

DannyK

Trusted Information Resource
#5
Hi,

I performed an ISO 13485 CMDCAS audit on a company that manufactured orthodontic archwire. (class 2)

I would encourge you to contact Health Canada to be sure if it is classified as a medical device.
 
B

bdsix

#6
It will be a Class II. Not sure why, but Orthodontic manufacturers like to use this custom made device defence a lot :) Be happy that Orthodontics has/had a strong lobby and avoided the "30 day rule" that the rest of the dental industry needs to deal with.
 
K

Katalina

#8
So, Romeotang, what did they say? You never did really describe your component, but I assume you were shipping the component to Canada and a dental lab there was using it to make the retainer? If it was the wire, I would say yes, it is a device, but I'm curious as to what Health Canada had to say!

BDSix - if the orthodontic OR dental product would fit you and only you, I say it is custom. Most orthodontic brackets and archwires are NOT custom. But some are created based upon the impression of your mouth, like a crown for dental products.
 
B

bdsix

#9
Katalina,

If you manufacture devices that are fit for each patient and have the same indication over and over are you truly making a custom-made device as defined in the CMDR?

Your dental crowns example for instance, is a good example of a custom fitted device not a custom-made device. Manufacturers who sell crowns are selling a mass produced product with a predefined indication. A crown could be preformed or an unformed block of ceramic to be milled, but in both cases you have the same intended use. There's really nothing unique except for the fitting so you need to be careful when trying to slot devices into that custom-made category.

Honestly, unless it's truly a custom-made, one-off, device, I personally would not go through the hassle of the Special Access program just to save on CDMCAS/licensing costs, etc.
 
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