3D print OnX on Nextdent?

[Beautidental]

Has anyone tried printing OnX from SprintRay on a Nextdent 5100 printer?

 

[mightymouse]

It’s not a matter of if but should. OnX is only validated for Sprintray. If FDA comes in and concludes you’re using a resin not validated for Nextdent you will be fined. To answer your question pretty much any resin can be printed if the light source is compatible and you play around with the settings. Just don’t put it into a patients mouth.

 

[Affinity]

Could you please cite an example of someone being fined for this by the FDA?

 

[mightymouse]

I don’t have any. Just going off what the manufacturers of some resin companies (Desktop Health, Myerson and Keystone) all told me in person. I’m “assuming” as they all make resins they must have an inside dialog with the FDA as they go through them to be validated. In those conversations they must be signaling or directly stating this is coming. It’s one of those better be safe than sorry.

 

[Affinity]

Ah I see, so its like how all the other 3 letter agencies coerce people to do unnecessary things out of fear of an 'audit' or fine. I will let you know if the FDA ever shows up at my lab..

 

[Datguypeter]

Ah I see, so its like how all the other 3 letter agencies coerce people to do unnecessary things out of fear of an 'audit' or fine. I will let you know if the FDA ever shows up at my lab..

Id be pissed if my dentist put something in my mouth that wasnt approved by the fda.
I dont think protecting the general public from shady labs is unecessary.

 

[Affinity]

You think the FDA protects people? You think they regulate or even know what labs in china send here!? The FDA approves all sorts of harmful products, until so many people die that they have to get pulled off the market so the class action doesnt get too big.. While never admitting to negligence. Doesnt sound very effective. Then again, lots of people think big brother is there to protect the general public.

 

[Affinity]

The only reason that the FDA approved it, is because they requested (and PAID) for them to evaluate their own R&D on a product. Of course it will only work in their printer, because thats the only way it was tested. Just like how e.max can only be pressed in an Ivoclar oven.

 

[Foggy_in_RI]

The FDA does not approve products by means of testing. You submit information to them and they review it but assume your data is accurate.

I wouldn't be surprised to see some change regarding how much you must disclose about the MEDICAL DEVICES you are manufacturing:

NASEM report: FDA should disclose drug and device manufacturing information | RAPS

To ensure resiliency in the medical supply chain, the US Food and Drug Administration (FDA) should publicly disclose the location of all manufacturing facilities that supply ingredients and parts for pharmaceuticals and medical devices approved in the US, according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM).

“The manufacturer for a pharmaceutical drug should be required to publicly disclose the manufacturing location, in particular the FDA Establishment Identifier (FEI),the city, and the country for the finished dosage form (FDF),active pharmaceutical ingredient (API, major excipients, and major packaging and delivery devices for all pharmaceutical drugs sold in the United States,” said a report summary.

The same recommendation also applies to devices; device manufacturers should publicly disclose the manufacturing location in the FEI, the city and the country involved in the device’s manufacturing and final assembly.

 

[Affinity]

Thanks, Im not sure if I was clear, because I said 'they'.. The manufacturers do the testing, the FDA reviews and approves it. FDA does not do testing, they are a regulator. FDA will say "printing this material in this wavelength is acceptable, but you can only use the approved machine creating the light source, any other source of light, is considered illegal production' Unless you do your own testing and get approved for your manufacturing application.

The fact is, its a temporary, if you arent printing or curing it right, it will probably break, and you will remake it. No FDA needed to figure that out. If you do things that waste your time and resources, its not illegal, its just dumb. Anyone who thinks pressing emax in a denture press is a good idea, well, Id have to agree, low overhead is a good idea.. haha

 

[Doris A]

Thanks, Im not sure if I was clear, because I said 'they'.. The manufacturers do the testing, the FDA reviews and approves it. FDA does not do testing, they are a regulator. FDA will say "printing this material in this wavelength is acceptable, but you can only use the approved machine creating the light source, any other source of light, is considered illegal production' Unless you do your own testing and get approved for your manufacturing application.

The fact is, its a temporary, if you arent printing or curing it right, it will probably break, and you will remake it. No FDA needed to figure that out. If you do things that waste your time and resources, its not illegal, its just dumb. Anyone who thinks pressing emax in a denture press is a good idea, well, Id have to agree, low overhead is a good idea.. haha

And who knows how long it will take to get the FDA to approve anything!!! For example, there is an MRI machine out there that is QUIET, no headache causing slamming , banging, etc. They've been waiting for FDA approval for TEN years!! I've had 2 MRI's this month and I'm going to be having another one next month, I wish they'd hurry up with the approval.

Sorry for hijacking this thread.....Back to original programming!

 

[Affinity]

Its the same in our industry.. NT Trading was selling metric tons of their abutments in europe for probably a decade before we were able to use them here.

Sorry for using logic, I know that means nothing to the FDA, but what was this printable material tested for? Breakage? Light absorption? Did they take tissue biopsies to see if it leaches into tissue? HA! of course not!
They just rubber stamped the application after the check cleared.

On another point, show me how, legally, the FDA or any gov entity can come to your workplace and examine your operation without a search warrant. If they do get search warrants, Id love to see one. If not is sounds like a violation, or a loophole.

FDA inspectors are invited in for compliance, not a bad thing, Im just saying, is anyone really worried about an FDA inspection or audit unless you are a huge operation?

 

[Foggy_in_RI]

Um- you're choosing to work in a regulated industry meaning you are subject to those regulations and audit/inspections. Don't like the idea of the FDA showing up at your workplace? Don't make regulated products I guess.

Just like OSHA inspections- if you are located in a state governed by OSHA and meet the requirements where you must comply with their regulations they have the right to inspect your site.

So yea- what warrants do you think you are owed?

 

[Affinity]

Its called the 4th amendment if that matters anymore.

I dont make regulated products, everything I use is FDA cleared, everything is documented. That is besides the point. Im not advocating for obfuscating medical regulations.

So youre saying, that the FDA, has the right to enter my workplace at any time and request something of me, with no notice, because OSHA? Sounds legit. Im not a lawyer, but Ive never heard of this, I would like to know from @keith goldstein , if the FDA can randomly inspect the dess operation without any notice..

Im not saying they cant request your documentation.. Its obviously best practice to use the best R&D products.. The FDA is an expensive rubber stamp on them, which proves they are worth the effort of mass production.

Im saying that if you are a big dog that joins the yacht club, you too can have your product FDA approved, this is the standard. They approve the untimely death of tens of thousands of people a year, so that is a low bar.

 

[Foggy_in_RI]

Not linking FDA and OSHA.

They can both independently show up at your work site, if you are subject to their respective regulations, unannounced.

It happens.

 

[doug]

Not linking FDA and OSHA.

They can both independently show up at your work site, if you are subject to their respective regulations, unannounced.

It happens.

Someone is going to have to file a complaint for that to even be a thought to them. They aren't on a hunt and are seriously understaffed.

 

[Affinity]

No, I think youre right, FDA and OSHA are linked to be able to enter and inspect..

Authority of OSHA and FDA in establishing and enforcing standards relative to electronic product radiation | Occupational Safety and Health Administration

www.osha.gov

1903.3(a)
Compliance Safety and Health Officers of the Department of Labor are authorized to enter without delay and at reasonable times any factory, plant, establishment, construction site, or other area, workplace or environment where work is performed by an employee of an employer; to inspect and investigate during regular working hours and at other reasonable times, and within reasonable limits and in a reasonable manner, any such place of employment, and all pertinent conditions, structures, machines, apparatus, devices, equipment and materials therein; to question privately any employer, owner, operator, agent or employee; and to review records required by the Act and regulations published in this chapter, and other records which are directly related to the purpose of the inspection. Representatives of the Secretary of Health, Education, and Welfare are authorized to make inspections and to question employers and employees in order to carry out the functions of the Secretary of Health, Education, and Welfare under the Act. Inspections conducted by Department of Labor Compliance Safety and Health Officers and representatives of the Secretary of Health, Education, and Welfare under section 8 of the Act and pursuant to this Part 1903 shall not affect the authority of any State to conduct inspections in accordance with agreements and plans under section 18 of the Act.

I wasnt trying to derail this but its an interesting point.

To the OP, its always a good idea to do things by the book and not mix and match.. but, if you understand the science that material cures at a certain wavelength, and ultimately, the Dr understands any risk involved (which is yet to be determined, FDA approval does not equate sucess or failure)
The Dr accepts the application, and is immune from liability, the lab takes all the risk, if any. I would consider it a grey area, and the risk of a penalty would come if you are mass producing and having considerable failure. Take vioxx as an example, Drs prescribing it are immune from liability (I assume) because it is FDA approved, but it killed 30,000+, so the manufacturer is still liable and being sued for billions. FDA, zero liability!
Risk/reward ratio.

 

[Affinity]

Users first post is one sentence and were off the rails.

 

[Affinity]

The FDA does not approve products by means of testing. You submit information to them and they review it but assume your data is accurate.

I wouldn't be surprised to see some change regarding how much you must disclose about the MEDICAL DEVICES you are manufacturing:

NASEM report: FDA should disclose drug and device manufacturing information | RAPS

To ensure resiliency in the medical supply chain, the US Food and Drug Administration (FDA) should publicly disclose the location of all manufacturing facilities that supply ingredients and parts for pharmaceuticals and medical devices approved in the US, according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM).

“The manufacturer for a pharmaceutical drug should be required to publicly disclose the manufacturing location, in particular the FDA Establishment Identifier (FEI),the city, and the country for the finished dosage form (FDF),active pharmaceutical ingredient (API, major excipients, and major packaging and delivery devices for all pharmaceutical drugs sold in the United States,” said a report summary.

The same recommendation also applies to devices; device manufacturers should publicly disclose the manufacturing location in the FEI, the city and the country involved in the device’s manufacturing and final assembly.

This link is a report of recommendations for supply chain resiliency, not law, although it might be similar. It also says to secure 'failure to supply' contracts with distributors , but I dont see anyone wanting to sign a contract with me if they run out of abutments.

However its actually a useful link if you read through it! I see your point, that the law could follow the recommendations.

 

[bigj1972]

The real message to take from all this discussion......Nobody gives a sh*t,
Patients, dentists, labs are all a mix of scholars, dumf*ks, and cheap-asses.

People are gonna drive past the posted speed limit. Some will get away, some will get a ticket, and some will die in a crash.
Authority created those speed limits to generate revenue, acquire data, and clean up the mess......not for your protection, but to justify their existence.