Dental application - medical product or not?

[Daliane]

Hello all
my client has an innovation for cosmetic removable dental arch (like snap on smile, please check on google to get an idea), which is used for cosmetic purpose only, not for curing or other medical purpose.

In EU cosmetic products are not classified as medical devices. What about FDA? I could not find a product code of a similar product on the website. Do cosmetic dental application need to be classified and get FDA approval?

Appreciate any feedback.

Thank you!

Daliane

 

[Tidge]

I (with no expertise on this sort of product) suspect that your device meets the definition of a medical device.

...quoting from linked page (with my emphasis)...

The FDA defines a medical device as:

• "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

 

[William55401]

hello Daliane. Suggest you look at a big dental provider like Patterson Dental and look at their device listings. Enter "Patterson" under Establishment name. They have hundreds of them. The device listing will tell how that particular product is regulated. A 5 minute search shows temporary crown / bridge made of resin as having a listing. Here's an URL that may get you going. My gut says this is a device. I know you will do your own due diligence.

Establishment Registration & Device Listing

Edit: FDA also accepts questions. DICE office. This board is a great resource. Going to the authoritative source may be a better strategy.
Contact Us – Division of Industry and Consumer Education (DICE)

 

[Watchcat]

Cosmetic products are not regulated as medical devices in the US, either. The question is whether FDA thinks your product is a cosmetic or a medical device. (Really the same thing is true in the EU.) Tidge has posted FDA's definition.

I think FDA's framework is much messier than the EU's, starting with the dubious notion of "substantial" equivalence, made messier by its implementation. It's all about the "intended use" but often it is hard to draw a straight line between a medical device's actual intended use and its intended use as articulated in the applicable classification regulation. IMO.

Snap-On describes its product as a dental arch that is an alternative to veneers, implants, and dentures. All three products can be claimed to serve cosmetic and/or medical purposes. However, I personally am unaware of any argument to be made, that veneers serve anything but a cosmetic purpose. And yet they seem to be regulated by FDA as a Class II device., under Product Code ELL. On the other hand, it is hard to say whether Den-Mat has listed the Snap-on with FDA , since it may have "folded it in" under one of its existing 510(k)s (eg, the same used for its veneers) or it may have decided it wasn't FDA-regulated.. The fact it must be prescribed by a dentist is also a regualtory attention-getter.

Of course no one can tell you what is and is not "required" for your product, especially based on such limited information. For purposes of FDA regulation, I personally would be inclined to consider it a medical device for whatever reason FDA thinks veneers are medical devices (even though I don't know what those reasons are), I might try to make the case that it is a Class I rather than a Class II, depending on its risk profile.

 

[blackholequasar]

As an aside to Watchcat's post... I used to work in contact lenses for years with B+L. We were heavily regulated by the FDA and also 13485 - as a class II medical device. However, you can go online and purchase contact lenses that are NOT medical devices because they claim to be used for cosmetic purposes. (But enjoy the infection you'll get after for using a non-sterile product in your eyeball)

This is a loophole that a lot of folks use to their advantage. the FDA does not regulate cosmetic devices as a medical device. I would believe that veneers could easily be a part of that. But buyer beware on purchasing something that does not have the regulation behind it to make the consumer feel safe, tbh.

 

[Watchcat]

I don't consider it a loophole. If they are actually being sold for cosmetic purposes only (e.g., brighter eyes, better eye color), then I think they are, in fact, not medical devices, which is to say, they are not contact lenses as defined by FDA regulations. If they claim to improve vision, then it's still not a loophole. Then they are medical devices and FDA simply hasn't caught them at it yet, or it has decided to exercise its enforcement discretion and not pursue them.

The makers of contact lenses that have registered with FDA and listed their lenses as Class II devices could do exactly the same thing, only theirs is a very competitive space with big bucks at stake, so their competitors would blow the whistle and raise a ruckus in the press if FDA didn't DO SOMETHING about it. I would expect contact lenses being marketed as for purely cosmetic purposes are sold much cheaper in a much less competitive market, so nobody cares. It's always about the money, not the adverse events.

 

[Watchcat]

temporary crown / bridge made of resin

Crowns and bridges are intended for use as protheses...to replace a missing or damaged body part (tooth) for the purpose of providing the same function as the missing body part (tearing/grinding, depending on the tooth). That's not how I see the Snap-On Smile. Both are temporary, but crowns and bridges are put on by a dentist and intended to remain in place until a permanent crown or bridge can be made, then are intended to be replaced by dentist, while the Snap-On is apparently intended to be easily put on and removed by the user at their discretion, with no permanent replacement planned.

 

[Daliane]

Product Code ELL.

When I look for the code it says "Teeth, Porcelain", what made you think veneers are included?

 

[Watchcat]

Because Denmat, the manufacturer of Snap-On, also makes Lumineers and has them listed with FDA under Product Code ELL.

This what I meant when I said that "often it is hard to draw a straight line between a medical device's actual intended use and its intended use as articulated in the applicable classification regulation." To me (and most people, I would think, Lumineers are clearly not teeth. And yet, it seems that FDA accepted Denmat's claim that they are "substantially equivalent" to teeth. This is probably because FDA's historical vision of dental products seems to have been grounded in the material of construction "If it's made out of porcelain and you put it in the mouth, it's a tooth." Go figure. That was in 1989. What it would do if it had to make the same determination today, who knows.

What can I tell you, I personally hate the 510(k) framework, but there it is. Whether Denmat considers its Snap-On Smile product to be covered by the Lumineer 510(k) (meaning it considers Snap-On to be a porcelain tooth for the same nonsensical (IMO) reasons that it considers Lumineers to be porcelain teeth, I can't say. Maybe it doesn't think has the Snap-On listed with FDA at all. because it doesn't think Snap-On is a medical device, I can't say, either. (When I say "think," I mean this is its position on the matter, whether it really "thinks" that or not. It may really think the whole thinking is as nonsensical as I do.) There is a reason many medical device companies have never entered the US market, in spite of its potential profitability.

If you hired me as a consultant, I could spend some time pursuing the matter further, but, this is FDA, so no guarantees I could come up with "the answer," just more information to inform your company's business decision, on how to proceed when there is no answer. (How's that for a sales pitch?)

Per William's post, you can also try asking FDA for free, but there will be no guarantees behind its answer, either. And I personally have found the quality of the response from DICE to be highly variable. Or you can pay FDA several thousand dollars to get a more considered answer that it still advises is "non-binding."

Asking FDA for free seems like a no-brainer...can't hurt, might help. But it may also establish a record of what FDA told you, which some companies worry might come back to haunt them later. Some even pay consultants to ask on their behalf, so FDA won't know which company wants to know. I'm inclined to think they are overestimating FDA's ability to keep track of things, but maybe not.

Given that you don't get a guarantee from FDA even if you pay, I generally think you would get better value if you spent what would probably be a good bit less for a consultant's guidance, since they are trying to serve your interests, while FDA serves its own. Still, in the end, the consultant might advise you to pay several thousand dollars to get FDA's "non-binding" answer. I probably wouldn't, but it gets the consultant off the hook, so some would. And some just don't think all that hard about whether it really makes sense to spend several thousand dollars for a "non-binding" response from FDA, because it's not their money being spent.

And who says working with FDA regulation of medical devices isn't fun, LOL.