FDA & milling abutments in house

[JMN]

...Micromanaging should not be the goal of the feds...

Our gov't bodies no longer concern themselves with what they should do, but what we should do. Micromanaging is good for business if your business is bureaucracy. The power structure has inverted.

Maybe just skip Bernie and go straight to CPUSA, the difference is negligible between the two and we're already nose down, why not push the throttle forward so the ramifications of personal responsibility abdication becomes startlingly apparent to people who want the gov't to take care of them.

end rant
I'm gonna go jump on the bed till the caffeine wears off.
Oh Mountain Dew I love you, I hate you

 

[RJS8669]

The big implant companies appear to be behind this. They sell uclas .They don't like it when you use 3rd party components and they don't like it when you mill your own abutments.
Why is Sirona the only one approved? Dentsply.
That would explain the email from Atlantis I received.

I think you are correct. The implant manufacturers are the ones who will reap the benefit of this decision. Aside from selling the UCLAs, almost all of them operate their own milling centers that are FDA compliant. I would bet that we will soon see direct-to-the-dentist marketing and a rise in fees charged to laboratories.

 

[rkm rdt]

Who knows where this will lead to?

 

[JMN]

I think you are correct. The implant manufacturers are the ones who will reap the benefit of this decision. Aside from selling the UCLAs, almost all of them operate their own milling centers that are FDA compliant. I would bet that we will soon see direct-to-the-dentist marketing and a rise in fees charged to laboratories.

There is an interesting wrinkle here also, Nobel's UCLAs are going up in price and CAD/milled abutments from the same company are going down. Is this the same with other companies?

 

[Sheldon Lerner]

Hi
I'm new here and in the interest of being totally open. I'm the CTO of an implant company.

I ended up here because someone forwarded the FDA alert to me.

I found it confusing that it listed only Sirona as certified to produce software to mill a custom abutment around an existing titanium base abutment or abutment blank.

Am I to understand that 3shape, exocad, and Delcam are outside of the law because they have abutment design software? What about the CAM software that actually interprets the Cad design such as sum3D etc and is used by the milling machine to produce the parts, are they also included in this ?

Or am I to understand that 3shape , ( perhaps exocad),which recently required that new libraries supply FDA approval in order to be in future releases, does in fact comply?

Finally, is this just a question of using approved software and materials that already have FDA approval, such as approved titanium bases and approved cad cam milling blanks? Would the lab have to have quality control documents and Registration and rely on the FDA 510k for the premilled blank or titanium base?

It's hard to believe a 510K for every abutment custom produced would be required. ( I'm not talking about prefinished blanks or Tibases) . Such documentation and submission would cost multiple 10's of thousands of dollars per submission and take months. This would clearly eliminate all custom abutments. As each one designed would require approval.

Finally am I correct in deducing that all custom abutments made from scratch from a titanium disc would be problematic under this ruling?

Thank you in advance for clarifying this. I have quite a bit of FDA experience, but this is somewhat new teritory for me. I can contribute in understanding FDA compliance from a manufacturing standpoint.
Best
Sheldon Lerner

 

[doug]

For those who are concerned, please email your questions to Bennett Napier at [email protected] As many of you know, Bennett is the association director for both the NADL and FDLA. There is more information coming after next week, and he would like to be able to create a FAQ that will help all of us better understand what is going on. Bennett is not a member of this board so he will not be on here to answer questions. This is evidently a complicated issue as he said their phones have been ringing off the hook all day.

 

[Gru]

I don't disagree. I think their rationale is that you can't really change the correction (post) angle all that much when modifying a stock abutment.

They don't seem to be paying much attention to UCLAs, for whatever reason.

Maybe because they make a fortune on the UCLA abutments? Where else could you sell more or less a half gram of gold and a plastic piece for over $200? Any way you price it, leave my UCLA's out of it!

There is an interesting wrinkle here also, Nobel's UCLAs are going up in price and CAD/milled abutments from the same company are going down. Is this the same with other companies?

Gold, even half a gram costs them a little. Titanium, not quite so much.

 

[grantoz]

Ive got a question for you guys how does all on 4 done with temp cylinders and plastic not get nailed by the FDA for using materials in permanent solutions that are only meant to be temp once you screw them in .Ive heard all the reasons like they are long term temps etc but most are screwed in and left for years .You dont leave a denture in the mouth for even days on end yet a lot of all on 4 restorations this is what they do.

 

[Affinity]

I have a pic I will have to share of some implant crowns that came out of a Pts mouth that were done with cerec crowns over temp abutments or maybe even cut down impression copings.. not sure. Why are the Drs not held to any kind of FDA standards?

 

[2thm8kr]

I have a pic I will have to share of some implant crowns that came out of a Pts mouth that were done with cerec crowns over temp abutments or maybe even cut down impression copings.. not sure. Why are the Drs not held to any kind of FDA standards?

Because they have a strong group of lobbyists.

 

[rkm rdt]

Because they have a strong group of lobbyists.

You mean the implant companies?

 

[2thm8kr]

You mean the implant companies?

Both

 

[JMN]

Ive got a question for you guys how does all on 4 done with temp cylinders and plastic not get nailed by the FDA for using materials in permanent solutions that are only meant to be temp once you screw them in .Ive heard all the reasons like they are long term temps etc but most are screwed in and left for years .You dont leave a denture in the mouth for even days on end yet a lot of all on 4 restorations this is what they do.

It's less about the facts than about the presentation of facts. Fee,Donation, Bribe, Consideration. These all have the same thing happening, but when a transaction occurs as one different rules apply even if all 4 could be said to be occuring. It's all about paperwork presentation.

 

[JMN]

Maybe because they make a fortune on the UCLA abutments? Where else could you sell more or less a half gram of gold and a plastic piece for over $200? Any way you price it, leave my UCLA's out of it!



Gold, even half a gram costs them a little. Titanium, not quite so much.

Costs them very little, with gold prices going way down, I think there may be additional reasons for their price inversion. CadCam abutments were more than ucla, then ucla prices went up. Not a big fan of Sweedish buisness practices.

 

[Affinity]

Costs them very little, with gold prices going way down, I think there may be additional reasons for their price inversion. CadCam abutments were more than ucla, then ucla prices went up. Not a big fan of Sweedish buisness practices.

I think you mean Swiss not Swedish.. Nobel and Straumann are both Swiss companies... They are both clawing for market share...


Ill also add that both of those companies were pretty much the originators and innovators of dental implants for a long time now.. Using very expensive machines, very expensive skilled labor, very expensive R&D, doing business in a country that is one of the most expensive in the world.. just a thought.. Theres a reason they call it a 'Swiss' turning machine..

 

[rkm rdt]

I think you mean Swiss not Swedish.. Nobel and Straumann are both Swiss companies... They are both clawing for market share...


Ill also add that both of those companies were pretty much the originators and innovators of dental implants for a long time now.. Using very expensive machines, very expensive skilled labor, very expensive R&D, doing business in a country that is one of the most expensive in the world.. just a thought.. Theres a reason they call it a 'Swiss' turning machine..

Well Swiss time is running out,
it seems that we will lose the race.

 

[RJS8669]

Had an interesting discussion with someone with inside FDA information. The issue seems to derive from a worry about labs using CAD/CAM systems to create abutments or screw-retained restorations that exceed angle correction specifications for FDA-approved implants. In other words, they don't want a non-FDA compliant abutment or restoration causing the failure of an FDA-compliant implant. The suggestion was, in order, to be on the safe side of things, a lab would need to register with the FDA (cost appx. $3800, and rising every year); and institute a Quality Management System to track lot numbers, designs, failures, etc... It was suggested that the total cost to be FDA compliant would be somewhere in the $7500-$10,000 range for the average lab - potentially more.

Other insights include that using CAD/CAM (with the exception of Sirona) to design/mill ANY abutment head or full contour restoration for a Ti base is a violation of the ruling, although it appears to be perfectly okay to hand wax and either press or cast whatever you like - go figure. The other really odd thing was that dentists are allowed to ask for a lab to mill an abutment or a screw-retained restoration, but a lab cannot market the ability to do so unless they are FDA registered and in compliance. So, this is aimed squarely at labs - there is no consequence to doctor for using a non-FDA compliant product as long as they knowingly request it. I believe this was referred to as "going off-brand".

Lastly, abutments have been labeled as a medical device and will be subject to the medical device tax. It appears that the entity milling the abutment or the entity selling the pre-milled Ti blank will be liable for collecting the tax. So, labs that outsource to FDA compliant milling centers should be charged the tax but are not liable for collecting a tax from the dentist or patient. If you are FDA compliant and milling your own abutments then the Ti blank supplier would collect the tax.

I have also been alerted that Nobel and Straumann will be issuing statements on this ruling in the very near future..

 

[JMN]

Well here goes the neighborhood. Why don't we just pack up and move enmasse to China, Mexico or India.Pretty soon (okay in 20 years) we'lll be getting subsidised as a failing industry and the egg heads will wonder why.

 

[JMN]

I think you mean Swiss not Swedish.. Nobel and Straumann are both Swiss companies... They are both clawing for market share...


Ill also add that both of those companies were pretty much the originators and innovators of dental implants for a long time now.. Using very expensive machines, very expensive skilled labor, very expensive R&D, doing business in a country that is one of the most expensive in the world.. just a thought.. Theres a reason they call it a 'Swiss' turning machine..

I know a guy who worked at the Branamark clinic in Sweeden in the 80's-90's. Taught me some intetesting history on the process of how we got what we use today.

 

[2thm8kr]

The issue seems to derive from a worry about labs using CAD/CAM systems to create abutments or screw-retained restorations that exceed angle correction specifications for FDA-approved implants. In other words, they don't want a non-FDA compliant abutment or restoration causing the failure of an FDA-compliant implant

So labs are now liable for poorly placed implants?
Am I the only one that thinks this is total Bullsh1t!!?
This is absurdity at it's finest. The government protecting the interests of global corporations at the expense of small business once again.
Hope you can find the right combination of condiments to choke down this steaming pile!