NTI questions

[mightymouse]

So I have a doctor who is looking for a replacement lab to do there NTI. I have several questions regarding NTI.
1) Are they a licensed product (meaning do I have to get certified by who every holds the patent)?
2) If I design digitally and print do I have to register with the FDA?
3) Do I have to register with the FDA if I do them analog?
4) What's the best analog workflow (material/investing/etc).

Thanks in advance.

 

[JMN]

the term NTI is a registered trademark, you may make the same device, but not call it an NTI and the doc must not write NTI unless you can document permisssion to not provide the brand name device.

 

[mightymouse]

the term NTI is a registered trademark, you may make the same device, but not call it an NTI and the doc must not write NTI unless you can document permisssion to not provide the brand name device.

Thanks. Any thoughts on digital? Most classes I take all say make sure your FDA compliant for almost every product fabricated by means of 3D printing.

 

[JimBoydDDS]

Actually, you may not make a device that follows NTI Therapeutic Protocol without a license. Since the tech and trademark are no longer exclusively licensed to National Dentex, you can become a licensed provider. I am happy to provide the therapeutic/fabrication protocol and licensing. -Jim. [email protected]

 

[Doris A]

Actually, you may not make a device that follows NTI Therapeutic Protocol without a license. Since the tech and trademark are no longer exclusively licensed to National Dentex, you can become a licensed provider. I am happy to provide the therapeutic/fabrication protocol and licensing. -Jim. [email protected]

Provide it here for all of us to see. Please and Thank you!

 

[Affinity]

Well isnt the NTI device pre-fabricated? So Im assuming you need the license to even buy the part.
Dr Boyd, does a patent on the shape of this device prevent someone from slightly modifying it and 3d printing it themselves?

 

[JimBoydDDS]

Provide it here for all of us to see. Please and Thank you!

Hi Doris. I'm happy to... I've tweaking a few things for a better presentation. Never occurred to me that I'd be asked to post it!

Well isnt the NTI device pre-fabricated? So Im assuming you need the license to even buy the part.
Dr Boyd, does a patent on the shape of this device prevent someone from slightly modifying it and 3d printing it themselves?

Yes, there are pre-fabricated devices that a dentist can buy and must re-line and retrofit, but is still obligated to follow the therapeutic protocol so as to prevent any adverse outcome. When done correctly, the patient either improves, or has no response. Once a dentist buys an NTI "chairside" device, he can "resell" it to a patient. As far as shape goes, no two NTI devices are alike, but it's the adherence to a protocol that is patent protected. Obviously, you can 3D print a device that (hopefully) follows the protocol and nobody would be the wiser (I'm sure there are bootlegged devices being sold as "NTI" everyday). (but if you don't sell it, then you're in the clear). My biggest concern is that a dentist delivers his first "NTI" device to a patient who has an adverse reaction that could've been avoided. The dentist then concludes that they're no good, depriving another patient from an opportunity for relief.

 

[Affinity]

I thought dentists always follow the instructions!?

 

[JimBoydDDS]

I had mentioned in another thread that our blinded, placebo-controlled, cross-over study, show NTI protocol's effect on Chronic Migraine would be published soon. Times up: here it is. The "NTI-Duo" protocol was "fine tuned" in this study. If anyone's interested in being a licensed provider of the NTI-Duo and NTIplus, let me know. -Jim

 

[LuthorCorp]

So I have a doctor who is looking for a replacement lab to do there NTI. I have several questions regarding NTI.
1) Are they a licensed product (meaning do I have to get certified by who every holds the patent)?
2) If I design digitally and print do I have to register with the FDA?
3) Do I have to register with the FDA if I do them analog?
4) What's the best analog workflow (material/investing/etc).

Thanks in advance.

We have doctors that request NTI "styled" appliance (3-3 appliance, with a 1-1 block on centrals for example) and we design digitally and print the splints fine. Of course can be done manually but we have had great success doing them digitally and printing them. (Printing in Keysplint soft material),

The material we use is all Health Canada approved and we use it on a daily basis for our regular splints so don't have any issues with that. Those restrictions might be different depending on what state/province/country your working out of.