Myerson EMA snore appliance ??

[DentureDude]

anyone making these?
what do you think?

i have a doc asking if i can make them for him. he showed me the demo that comes from Myerson but i can tell the finished product is not going to look so clean and slick.

i checked out the video and my initial thought is .. they are just sticking the little side lug thingies on the model with wax? seems that could easily fall off or move out of place during the suck down process?

also wouldn't the side lug thingies be kinda big and bulky (and not defined) after the material is formed around them? not clean and slick with the defined "tack head shape" the way it looks on the demo?

also what if there is not enough natural retention on the patients arch to hold the thing in place while the two nightguards are pulling on each other all night?

if you have any experience with this i appreciate the reply.

 

[JohnWilson]

I do not make these devices as I am not registered with the FDA to do them. Furthermore the minor ammount of proffit from said appliance dictates that the juice is NOT worth the squeeze.

Look at glidewells silentnight, farm them out and be done with it, your life will be much less stressful!

 

[Flipperlady]

anyone making these?
what do you think?

i have a doc asking if i can make them for him. he showed me the demo that comes from Myerson but i can tell the finished product is not going to look so clean and slick.

i checked out the video and my initial thought is .. they are just sticking the little side lug thingies on the model with wax? seems that could easily fall off during the suck down process?

also wouldn't the side lug thingies be kinda big and bulky (and not defined) after the material is formed around them? not clean and slick with the defined "tack head shape" the way it looks on the demo?

also what if there is not enough natural retention on the patients arch to hold the thing in place while the two nightguards are pulling on each other all night?

if you have any experience with this i appreciate the reply.

No experience with these but have experience with docs asking me to make them. My answer is that I would love to but the FDA now wants techs to register with them to make these and the fees they charge would close my lab down (anyway something like that.) I know it doesn't help your problem but it's a way out of it if you want ;-)

After I posted this I saw John's post. What he said

 

[araucaria]

The 'first-step' is a different way of manufacturing to the permanent appliance. On the permanent EMA the lugs and occlusal platform are attached after forming the splints. Just contact Myerson, I'm sure they'll tell you everything you need to know for success.

 

[Doris A]

You have to make a practice one, send it to Myerson to be approved. Then they will certify your lab to make them.
Then you have to register with FDA.....Farm it out to Glidewell, they make them as well as the silent night.

 

[Kris S.]

Glidwell makes the EMA as well.

 

[DentureDude]

thanks for the replies.

does anyone know off hand whats the cost ..or approximate cost to be "FDA Approved" for this?

 

[Flipperlady]

thanks for the replies.

does anyone know off hand whats the cost ..or approximate cost to be "FDA Approved" for this?

Isn't it something like 2 or 3K per year or was it every three years, plus they can drop by at any given time.

 

[kcdt]

Don't forget that these are the category of medical devices you will be on the hook to pay the 2.3% excise tax on.

 

[DentureDude]

screw it.
i got better things to worry about.
after i jump through the hoops there gonna call glide anyways..
200 is going to sound much better than 350-400

thanks for the help.

 

[nicward1]

I have yet to see a reference in the FDA regulations require that dental labs register if they make sleep appliances. I have read all of 21 CFR 807 (especially 807.65) and have not come across anything that indicates that dental labs need to register with the FDA if they fabricate sleep appliances. If anyone can provide a reference to the contrary I would like to see it.

Aside from that, I have been making sleep appliances for over 9 years now and have found it a very rewarding investment.

 

[kcdt]

Are you an attorney? if not, you'd better start thinking about consulting one. From the ADA:
'The U.S. Food and Drug Administration requires registration for dental labs that operate overseas, serve as the initial importer for a foreign laboratory, conduct repackaging services or manufacture sleep apnea/snoring and other specific orthodontic appliances. "

If you are making these appliances, and you haven't registered, you're breaking the law. Simple as that.

 

[nvarras]

Baahhhh!!! It's only illegal if you get caught ; - )

 

[nicward1]

Are you an attorney? if not, you'd better start thinking about consulting one. From the ADA:
'The U.S. Food and Drug Administration requires registration for dental labs that operate overseas, serve as the initial importer for a foreign laboratory, conduct repackaging services or manufacture sleep apnea/snoring and other specific orthodontic appliances. "

If you are making these appliances, and you haven't registered, you're breaking the law. Simple as that.

The article from the ADA does not reference where the FDA mandates this. The article references an association with the NADL and the NADL has only referenced 21CFR807.65(i) which does not indicate that a dental lab needs to register with the FDA if they are making sleep appliances.

The ADA is not the FDA. simple as that.

Have you researched this yourself or are you taking someone elses word for it? If you could provide me with a source that refers to a section of the FDA that specifies dental labs that make sleep appliances needing to register with the FDA then that would really be helpful to everybody.

There is a reason that Myerson does not require labs making the EMA to register with the FDA. It's because they too have had their attorney's read through the FDA regulations and did not find any evidence indicating a need for dental labs to register with the FDA if they decide to make dental sleep appliances.

 

[kcdt]

I'm not trying to bust your balls. But many industry associations have had legal experts look into this (ADA, NADL,etc.).
With all due respect, Myerson's is in the business of selling product, not offering legal advice. their motive is to get you to purchase. Simple as that. The trade organizations offering guidance are motivated to protect their membership from problems.

I'm not telling you what to do- that's your choice, but don't whine if you're mistaken and it comes back to haunt you.

 

[nicward1]

I'm not wanting an argument or anything like that either. but when the trade organizations tell you something and the materials/references that they cite doesn't match up with what they are telling you then it raises more questions.

 

[kcdt]

Then I'd advise you do more due diligence than believing what the manufacturer/ salesman tells you. Thsi industry is replete with stories of manufacturers reps saying **** that isn't so as long as it gets you to purchase their product.
This is a CYA situation, and if you're mistaken, Myerson isn't going to do squat to bail you out of it, and that's the blunt truth.

 

[rlhhds]

I have yet to see a reference in the FDA regulations require that dental labs register if they make sleep appliances. I have read all of 21 CFR 807 (especially 807.65) and have not come across anything that indicates that dental labs need to register with the FDA if they fabricate sleep appliances. If anyone can provide a reference to the contrary I would like to see it.

Aside from that, I have been making sleep appliances for over 9 years now and have found it a very rewarding investment.

A device for sleep apnea is a class II medical device. If you manufacture class II medical devices you must register with The FDA. If you farm them out you need to register with the FDA as a reseller. So, I decided some time ago to completely forgo sleep apnea appliances. Save myself the registration fee and the exposure to the FDA.

 

[nicward1]

Just to be clear, I am not taking the word of Myerson regarding this issue. I only mentioned them as it was brought up earlier in this thread. I have personally read through title 21 CFR, have spoken with multiple people regarding this issue (including accountants and attorney's) and all have come to the same conclusion.

Dental Labs are exempt from registering with the FDA. If there were stipulations then they would be posted. Dentures and porcelain crowns are also categorized as Class II medical devices as well and yet dental labs that fabricate them are not required to register their facility with the FDA.

 

[AJEL]

Then your attorny decided snore appliances for you are not 510k devices? FDA regulation #872.5570 Device class 2
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=872.5570
Product Classification
and your accountant told you that you personally have no requirement of the

The annual establishment registration fee must be paid between Oct. 1, 2012 and Dec. 31, 2012. For FY 2013, the registration fee for each establishment is $2,575 US Dollars. There are no waivers or fee reductions for small businesses. Starting in FY 2013, all establishments must pay registration fees, regardless of establishment type or activities conducted.

Important Information on the Medical Device User Fee Rates for FY 2013
And that you are not required to fill out a form 720 to pay the tax on Snore appliances.

Taxable medical devices (IRS No. 136). The tax on the sale of certain medical devices by the manufacturer, producer, or importer of the device is 2.3% (.023) of the sales price. Enter the total sales price of all taxable medical devices sold during the quarter and the total tax due on the line for IRS No. 136.
A taxable medical device is a device that is listed as a device with the Food and Drug Administration (FDA) under section 510(j) of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 807, pursuant to FDA requirements. There are specific exemptions for eyeglasses, contact lenses, and hearing aids. There is also an exemption for devices that are determined by the Secretary to be of a type that are generally purchased by the general public at retail for individual use (this exemption is known as the retail exemption). See Treasury Decision (T.D.) 9604 for information on how to determine whether a device falls within the retail exemption, and examples of how a taxpayer might evaluate a given device.

Instructions for Form 720 (01/2013)

Dental laboratories are exempt from registration as long as they do not produce regulated appliances. Although a laboratory or supplier that manufactures the appliances or materials that are regulated is not exempt.
So I make Dentures and the class 2 parts I use to make them with in the USA must be FDA Certified and the parts and materials have a Device tax applied as of Jan 1, 2013. I choose to no longer produce devices (snore appliances that are therapeutic devices to control a condition as medicine does) that would require me to register and pay the registration fee and update my lab to a FDA level facility.
But that is what my Attorney & Accountant advised me to do. As the rules of the game changed with the Affordable Care Act Tax Provisions.
And I thought I had managed to get this all out of my head, at least until something new came up at :http://www.medicaldevices.org/