FDA 510K Implant abutment clearance

[brayks]

Thanks Tom, I clearly did. Thanks for the follow-up and your understanding.

I think you got my post wrong.

I give it in audio to many more people that my employees. Any twelve year old should have it presented by their parents and discussed after they read it. It a very good book. I never take off my running shoes and even with a room full of cheese I'm am out looking.

The Emyth Revisited is even better for the lab owner trying to make the transition for a one man lab to a full grown busniss.

 

[grantoz]

can you mill the abutment with a mill fda approved or not then run over the surface with a diamond etc then call it hand milled ?because thats ok if its hand milled, i know its a bit on the border but so is the whole approach from 3hitrona etc.

 

[grantoz]

Also the whole fda approved thing is about preformed blanks for abutments so does that mean also Zi pucks because i believe that its different to preformed blanks for sirona mills etc. Until i get some really accurate definitions i think not much can be acted upon by us or the fda.

 

[brayks]

can you mill the abutment with a mill fda approved or not then run over the surface with a diamond etc then call it hand milled ?because thats ok if its hand milled, i know its a bit on the border but so is the whole approach from 3hitrona etc.

That was my first reaction...

 

[grantoz]

so brayks what do you think of the 2nd post ie difference between premade blanks for 3hitrona and pucks of zi etc for real mills sorry couldnt resist.

 

[brayks]

so brayks what do you think of the 2nd post ie difference between premade blanks for 3hitrona and pucks of zi etc for real mills sorry couldnt resist.

Although I am aware of no specific FDA notification or correspondence regarding THIS point. I believe zirconia abutments manufactured from a disc are not at issue as it does not require the use of a pre-mill blank from a manufacturer requiring an FDA cleared component - 510(k).

Further, I believe zirconia prosthesis utilizing FDA cleared zirconia discs have pretty much been accepted by the FDA for CAD/CAM processing therefore no additional clearances are required of the zirconia disc manufacturer or the lab/milling center.

Also, based on reliability and fatigue damage studies made comparing zirconia and titanium abutments, a titanium fixture utilizing a TZP ZrO2 abutment is significantly less likely to fail due to divergence related issues than a titanium abutment.

This is largely due to Ti abutments being over twice as strong abutments made with Zr I know of one study that showed a test of Ti abutments that we truncated at 70,000 cycles of step-stress testing at a 900-N load with no fractures. The zirconia group had a nearly 50% failure rate (seven out of eight specimens failed) with MAX force of 400-N.

Again, just my thoughts and opinion (and I am clearly no expert)...

 

[grantoz]

So what this really means is either use sirona pay thru the nose or use normal Zi blanks everything is hunky dory better quality and less cost so what is the big deal then.Life is normal just some company trying to drill us again.

 

[keith goldstein]

I spoke to consultants involved with the creation of these guidelines and what they said was that custom abutment manufacturers are manufacturing a medical device and therefore need to have both GMP and QSR in place with a 510K.
The first companies are the largest ones that will have to go through this process and then trickle down from there.

Here's a brief overview on this- http://ask.trilinkbiotech.com/q-what-do-gmp-iso-and-qsr-mean-and-how-do-they-differ/

 

[vurban210]

I spoke to consultants involved with the creation of these guidelines and what they said was that custom abutment manufacturers are manufacturing a medical device and therefore need to have both GMP and QSR in place with a 510K.
The first companies are the largest ones that will have to go through this process and then trickle down from there.

Here's a brief overview on this- http://ask.trilinkbiotech.com/q-what-do-gmp-iso-and-qsr-mean-and-how-do-they-differ/

Keith, what guidelines are you speaking of? I've yet to see any guidelines from the FDA, and have even been told that this goes back something that was said, at some meeting, at some time, in 2014.

But what I really found interesting was this passage from the NADL release:

"NADL was recently requested by an industry trade publication to peer review the contents of a pending article and advertising that made claims on the milling of CAD/CAM abutments. As part of NADL's due diligence, the association reached out to FDA to confirm the actual FDA positions."

Everyone is aware of what this means correct? I'm sure you all opened your IDT this month right? Page 37?

This was a marketing driven created crisis, and you know what - in the short term the NADL made things worse by getting involved. It is all politics, all the time. All you have to do is follow the money.

Meanwhile the FDA is trying to enforce archaic 20th century rules that simply are not applicable to the products we are working with. Can someone, anyone at all, please tell me how milling by hand is ok but it is not ok to mill on a automated machine? I just can't wrap my mind around that. I mean, you want to say they can't be milled at all, fine, I can at least understand the concept with that.

Dunno, but hey everyone make sure to pay your yearly annual registration fee, file your 510K and pay your fee, and oh, by the way they will probably want to be getting that 2.3% excise tax form you now. Maybe the NADL can "perform some due diligence" and have a chat with the IRS on behalf of all of us.

 

[vurban210]

Just to be clear, I think smart, clear and measured regulations are necessary part of making sure that things in this world are safe. But the problem with the FDA specifically is that they do a very poor job of making smart or clear or measured regulations. The more complicated they make it the more money they can make when they leave the public sector and join the private sector as a "consultant".

Who better to charge you $300 an hour to decipher the regulations than the person that helped write them?

 

[keith goldstein]

From my limited knowledge the guidelines would be what are the requirements to ensure that the lab has GMP and QSR in place and that to obtain what those are specifically requires calling the FDA and obtaining that information.
I know of two consultants that are working on a service to ensure labs comply and I sense it is a work in process still.

 

[TheLabGuy]

NADL on the 9th will post their understanding of the law, and what it will take to be compliant.

I haven't seen this yet, anyone else? It's the 15th now.

 

[2thm8kr]

I haven't seen this yet, anyone else? It's the 15th now.

[URL="http://dentallabnetwork.com/forums/threads/nadl-fda-discussion.21742/#post-197226"]NADL - FDA discussion[/URL]

 

[Andrew Priddy]

I see a lot of posts about people reading into this whatever they want to.. even the NADL understanding isn't even straightforward enough for anyone to understand what they can or can't do.

I really don't see how this can affect much in the way of everyday production for an average lab .. aside from the 2015 3shape library lockdown, not much will change.. at least not overnight/instantly.

there is way too much hype around this to even have an informed decision... the reality is, we will be making what we want/ need to, in the best interest of the patient.
our duty is to preserve oral health.

we all know that regulations, and enforcing regulations are two different things. there would need to be trained technicians working in the field for the FDA. I honestly don't even think the FDA knows what they want or what they are doing.

also, what about the bigger picture? what about the overseas implant companies that don't give a crap about what we are capable of doing or not doing from an FDA regulation standpoint?

the bottom line is that the case will need to get done.. will get billed out based on the work done, and the patient will get the best restoration we can offer

 

[vurban210]

The fact is the cheap dime-store consultants have arrived.

The whole thing smells like a set up to me. This lab that is advertising that "your abutments may be illegal" what is their vested interest? Or are they just being propped up by a certain company that just so happens to be one of the only companies with a system in place?

Seriously, did anyone else read the beginning of the NADL's document?

And I agree with Andrew that the FDA is clueless about what they are doing.

 

[Yourgoes]

Purpose.... They say the FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

there is way too much hype around this to even have an informed decision... the reality is, we will be making what we want/ need to, in the best interest of the patient.
our duty is to preserve oral health.

I'm not sure patients will be any safer or will be getting higher quality products following this ruling, but I'm certain they'll be paying more for it... Gotta hand it to the lobbyist who managed to pull this off. Perhaps a relative of Calvin Song... j/k... I hope....
Seriously though, this is an issue that is caused by dentists, how can the FDA prevent them from doing what they shouldn't do?

 

[vurban210]

Seriously though, this is an issue that is caused by dentists, how can the FDA prevent them from doing what they shouldn't do?

They can't, because the dentists have the ADA protecting them. Funny, I would like to hear the ADA squeal if the FDA was telling them that any dentist placing an implant had to register and gain 510K clearance. I'm sure we've all seen our fair share of facepalm cases where it seemed like the doc was placing the implant with a blindfold.

 

[PDC]

The fact is the cheap dime-store consultants have arrived.

The whole thing smells like a set up to me. This lab that is advertising that "your abutments may be illegal" what is their vested interest? Or are they just being propped up by a certain company that just so happens to be one of the only companies with a system in place?

This reminds me of the similar situations involving websites where music could be downloaded for free cutting out the royalties for the artists. Same thing with Rolex watches, signature handbags, clothing, etc. I think the major implant companies are behind this because they have the most to gain (or lose). They spent a lot of money on getting patents and they obviously want to protect them.

I guess the lab Vurban mentioned must have met all the requirements and paid the monies to whomever necessary to mill specific abutments. I know there are lots of milling centers who have invested a lot in machinery to mill abutments. Hopefully, there will be a reasonable time given for compliance. I could see the FDA imposing fines on those who don't. Another form of revenue for the gov't.

 

[Yourgoes]

They can't, because the dentists have the ADA protecting them. Funny, I would like to hear the ADA squeal if the FDA was telling them that any dentist placing an implant had to register and gain 510K clearance. I'm sure we've all seen our fair share of facepalm cases where it seemed like the doc was placing the implant with a blindfold.

Exactly what I was getting at.... it's like blaming the roofer for this. This is not where the problem originates. No chance they'd ever mandate guided surgery.

 

[LA Ceramics]

I just sent one of my dentists 3 separate items ;

- one Ti base
- one zirconia placement jig (shaped like an abutment)
- and one placement jig holder (shaped like a crown)

Oh darn,...I hope he doesn't have a tube of that Multi-link stuff