EMA & EMA FIRST STEP SLEEPING APPLIANCES

[phyllis]

We might start making the EMA First Step & the EMA final appliance for sleeping disorders. Just wanted some input on these appliances. I know we only need a regular thermoforming machine
for the "first step" appliance. Then I"ve been told that for the final appliance we need a Erkoform-3d with Occluform thermoforming machine from Glidewell. Which of course costs a pretty penny. Is this all worth it?
I know we also have to become certified for this.
Opinions please... and does anyone know of any place else we can buy one of these besides glidewell?
Or maybe there is another type of appliance that works and is worth us making them?

Thanks for any info you can give,
Phyllis

 

[AJEL]

You need a biostar, erkoformer or equal, the blanks come in round to start and the regular vac machines are not strong enough, they also require the timing program.
The problem with sleep apnea & why I stopped is patient compliance, & I was nervous about the new FDA, it isn't clear if when you get the cert from Myerson (you watch their video and complete one and send it in to them for evaluation.) if you are covered under their FDA or if you need to pay for your own. Maybe Tom will chime in or PM him, or just call him he is rather easy to talk with and shares. From what I have investigated if you go with any other you do need to purchase a FDA 510k to produce these type appliances.