Snoring Devices

[kimba]

Can anybody tell me their technique for making soft bimaxilary anti snoring appliances. I have made one using 2 mouthguard blanks with melted offcuts "glueing " the 2 blanks together at the desired vertical but the patient keeps tearing them apart. I usually only make a MDSA style appliances which are 2 piece , but patient wants a one piece soft appliance. Any help would be most appreciated

 

[JohnWilson]

First off are you registered to make a Class 2 medical devices? Do you feel that a few words of wisdom from techs on this forum are adequate to make you compliant to make such an appliance. The profit to make such an appliance and the hoops you need to jump through to be compliant in my opinion is not worth the trouble.

There are certain things I choose not to mess with and the FDA is one of them.

 

[kimba]

Thanks John , but I may have misrepresented myself. I am not supplying it directly to the patient. I am being provided with impressions and and an open protusive bite by a clinician. I am looking for techniques to produce a soft one piece appliance

 

[JohnWilson]

I understand but please do yourself a favor and understand that this type of appliance has certain regulations that you must comply with to be able to LEGALLY fabricate them. Knowing how to do it is not all that you need.

Its one of the few dental appliances that are regulated here in the US if you are out side the states your country may be different.

 

[kimba]

Thanks John, but I am in Australia. We have no such regulations other than not being able to supply them directly to the public.

 

[chief26]

john....educate me....when I first read th rules, I was very concerned. My concern was that any appliance that sets the mandibular forward and holds the bite open can be used as a antisnoring device. So, I called the fda to get more details on being compliant. I dont want to.have to worry. I was told that unless I was dealing internationally that I didnt have to do anything.

 

[ParkwayDental]

From what I've heard from Myerson their sleep apnea devices are pre FDA approved resulting in the lab not needing to have a class 2 medical device certificate. This came from Kris Shermerhorn when we were in Biloxi for the Fun & Sun meeting. Still skeptical though we haven't touched them and stay away as John stated.

 

[araucaria]

worth investigating kimba;
http://www.pressing-dental.com/pdf/resine/corflex_orthodontic-eng.pdf
http://www.pressing-dental.com/odontotecnica_en.html

 

[Tayebdental]

Be prepared to pay medical/dental device tax on these appliances.

 

[kimba]

worth investigating kimba;
http://www.pressing-dental.com/pdf/resine/corflex_orthodontic-eng.pdf
http://www.pressing-dental.com/odontotecnica_en.html

Thanks for that, am researching but it seems to need an injection machine, and I don't do enough to justify the expense. I was hoping for a simpler solution if it is out there. Thanks again though for your help