FDA 510K Implant abutment clearance

Zubler USA

Zubler USA

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Unfortunately, those 510k's (couldn't find the first one) are either old or for use with Sirona which at this point is the only CAD/CAM software that is FDA approved otherwise you must become an FDA certified milling center. It is true what is being said. However it is not impossible to become a milling center; but it is a lot of work!!! Think ISO 13485 certified and harmonized with the FDA GMP and QS. What we need is for 3Shape and DentalWings to become FDA approved. That would solve a lot of problems.

So Linda, you are a Regulatory Specialist. I assume you are very familiar with FDA Regulations. I see you submitted a 510K Application K141159. We have talked to our attorneys and do not get the same information we hear from the industry journals or competing companies. Given your experience, Whom would you speak to (specifically) for regulatory advice in this situation? Do you have a firm name or FDA representative that you may refer to by name? I am confident in our attorneys, but also value gathering intelligence from multiple credible sources.
 
keith goldstein

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I have had conversations with one of the scanner manufacturers and they are avoiding going through FDA process because are concerned that the FDA will put all these restrictions on what their software can and cannot do. Then this will also apply to the CAM, the mill, etc. Hence why Sirona is the only approved system. Which also means that all the closed scanner solutions from the implant companies are also not FDA approved. There are consultants that provide a process for dental labs to be FDA GMP and QS "approved". The entire ISO 13485 is a much larger more complex process in and of itself. DESS has this and should be a requirement for anyone manufacturing stock abutment components, ISO 9000 is not the same and not relevant to medical devices.
 
JKraver

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I understand how they care what materials we put in mouths, but how the material is milled is ridiculous. Once the government gets involved everything goes to hell, wouldn't be surprised if there was a countermovement back to casting with all the government bull**** they will impose.
 
keith goldstein

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All of the labs on this forum are dealing with this issue and would like to know if my statements and assumptions are correct or incorrect based on your knowledge and understanding of what was communicated from the FDA, the NADL, and other lab members.

Background Info
According to the NADL letter it states the only FDA approved custom abutment is from/made with a Sirona system.
One of the reasons for approving this system is that it has certain design limitations which cannot be bypassed when you design and mill out the restoration.

Questions -
If the design software you use does not have limitations on what you can design, according to my interpretation of the NADL statements then this design software and scanner are not FDA approved? is that correct or incorrect and if so why?
For example you can design a screw retained abutment crown that is too angulated, or too long or too wide, or too narrow at the base and if the software does not set parameters as to what you can design then there maybe a higher probability of failure.

Does the scanners from Nobel, Straumann, 3i, Zimmer and Atlantis have such limitations or parameters that prevent you creating this type of design?

If you make a crown on top of a custom abutment that you have fabricated from these companies and you make the crown in your office seperate and send to them or someone else to mill it does this mean that only some of your restoration is FDA approved but not the entire thing?

I look forward to your answers. Not trying to stir the pot but to gain some perspective from others as to what they know about this since it is making no logical sense.
 
2thm8kr

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I look forward to your answers. Not trying to stir the pot but to gain some perspective from others as to what they know about this since it is making no logical sense.

I am glad you are stirring the pot. There has been no clear information on this and there was a lot of talk about clarification at MidWinter, but nothing.
Logical sense and the US government do not go together.
 
JMN

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Saw a picture on Facebook this week with a crown on an implant running at a 45 down the ridge to the implant for a long ways. Who is responsible for policing that kind of stuff?

Seeing bad guys everywhere must make it hard to love what you do.

Late to the party. Isn't policing that stuff exactly what the practioners State Licenseing Board is all about? Not being 'smart', just thought that was the case.
 
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Linda Saylor

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So Linda, you are a Regulatory Specialist. I assume you are very familiar with FDA Regulations. I see you submitted a 510K Application K141159. We have talked to our attorneys and do not get the same information we hear from the industry journals or competing companies. Given your experience, Whom would you speak to (specifically) for regulatory advice in this situation? Do you have a firm name or FDA representative that you may refer to by name? I am confident in our attorneys, but also value gathering intelligence from multiple credible sources.

We have been speaking with the CDRH branch at the FDA, that specialize in dental devices. They are all very helpful and I am sure if you call or email them someone will reach out to you and you can get the conversation going. I have copied the url for the "FDA contacts page" below, about half way down the page you will see the device section and the people in charge of the Dental Devices. http://www.fda.gov/AboutFDA/Centers...uctsandTobacco/CDRH/CDRHOffices/ucm127854.htm

Right now, I am in middle of submitting two more 510k's (they are under review right now, cross your fingers for me!) and have a 3rd 510k is in the works with end user software validation. Becoming ISO 13485 certified and harmonizing our QMS with the FDA's GMP and QS so we can become a certified milling center is the only way to be in compliance with the new regulations; unless you use the Sirona System. That is the only software (sorry no EXOCAD) at this time that is approved. So it becomes more about "your process" than the software in the end, which dictates that you can ensure/prove that an abutment cannot be milled out side of the limitations the FDA is comfortable with. And do some rather expensive Cytotox/Bio-Compatibility testing to prove that your process does not leave any contaminates behind that could cause sensitization, irritation or be toxic, along with the normal fatigue tests. It's not cheap. It's not easy. But in the end it will worth all the work and cost.

Right now to be compliant we are currently having our patient specific abutments milled by a certified milling center, Argen. They had their process approved in K143051. If all you are doing is milling crowns you are golden for now. It's the abutments that have always had to have 510k approval that they are cracking down on and saying, if you mill the top/stump portion of an abutment you must have 510k approval for your process or use an approved software and system. They are trying to make sure everyone manufactures abutments the same way, to mitigate risk to the patient.
 
keith goldstein

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Hi Chris-
Is Zubler seeking FDA approval on- your machine, premilled interfaces, scanner, cam (all of them, some of them)?

It's the abutments that have always had to have 510k approval that they are cracking down on and saying, if you mill the top/stump portion of an abutment you must have 510k approval for your process or use an approved software and system.
It's the abutments that have always had to have 510k approval that they are cracking down on and saying, if you mill the top/stump portion of an abutment you must have 510k approval for your process or use an approved software and system.

Right now besides Sirona there is no "approved software and system" and the FDA is trying to set limits on how this design can be made which means that each software provider (3shape, dentalwings, exocad) needs to submit the limitations on what can be designed on top and to the best of my knowledge they have not done so nor do they plan to. I was told that often the distributors of these systems along with the CAM and Milling machines would submit an entire system to get FDA approved to fulfill that requirement. Do we know of any companies with these scanners, this software, and some cam and machine that has submitted an entire system to the FDA?

This would also mean that any interface that they are going to be using with their system would also need to be FDA approved and wouldn't that mean that the distributor of these systems would have to set limitations that their system would only accept these ti bases or milled block interfaces?
 
Linda Saylor

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Hi Chris-
Is Zubler seeking FDA approval on- your machine, premilled interfaces, scanner, cam (all of them, some of them)?


It's the abutments that have always had to have 510k approval that they are cracking down on and saying, if you mill the top/stump portion of an abutment you must have 510k approval for your process or use an approved software and system.

Right now besides Sirona there is no "approved software and system" and the FDA is trying to set limits on how this design can be made which means that each software provider (3shape, dentalwings, exocad) needs to submit the limitations on what can be designed on top and to the best of my knowledge they have not done so nor do they plan to. I was told that often the distributors of these systems along with the CAM and Milling machines would submit an entire system to get FDA approved to fulfill that requirement. Do we know of any companies with these scanners, this software, and some cam and machine that has submitted an entire system to the FDA?

This would also mean that any interface that they are going to be using with their system would also need to be FDA approved and wouldn't that mean that the distributor of these systems would have to set limitations that their system would only accept these ti bases or milled block interfaces?

The only "system" that I am aware of that is approved is the Sirona System. Once the CAD file is converted to an STL file and sent to the mill what ever you designed will be milled. So there is really no need to set a specific mill. (machining oils, cleaning process and final qc is another story though!) As far as any other CAD programs being submitted to the FDA for approval only they know.... and the CAD software companies wont say anything until it's cleared. I have hope for 3Shape because they have their implant software approved so they know the how and what the approval process requires but I don't think DWOS ever will because they want to keep their software open ended so it can be modified by the users. Exocad is so adaptable that I'm not sure they will either, but I do think you may see companies purchase an Exocad base and create their own software with set limitations and get approval that way. But again, that won't be cheap or easy either. But they could make a killing doing it.
 
doug

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Isn't it a matter of setting limitations in the software so that the user can't violate set FDA compliant parameters? Since the limits are FDA standards it would seem to be an east fix for all of the software providers
 
Linda Saylor

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Isn't it a matter of setting limitations in the software so that the user can't violate set FDA compliant parameters? Since the limits are FDA standards it would seem to be an east fix for all of the software providers

You would think so, and it would be in their best interest to do it, if they wanted to keep open software for EU then do it. But then that means dealing with 2 versions of their software....
 
keith goldstein

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Hi Linda:
You mentioned 3shape have their implant software approved...I have heard that all they did was block non FDA approved library files from their software. Please correct me if I am mistaken, but I do not think that they are approved by the FDA, nor is any other software as you mentioned besides Cerec. When I mean approved that their entire software is approved by the FDA which I believe is not. I believe the only way the FDA will approve a system with this software or any others is if it is a complete system such as Cerec. I know ZZ has exocad under the covers of their software and has tried for several years to get their parts FDA and does not have it (over 2+ years later) and the same with Origins and I am sure there are others.
 
JMN

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Isn't it a matter of setting limitations in the software so that the user can't violate set FDA compliant parameters? Since the limits are FDA standards it would seem to be an east fix for all of the software providers
Unfortunately, no.
They're all hopped up on catnip and even want to see how and how well you're cleaning them of all machining fluids and debris as a normal part of the process.

FDA is approving a complete workflow, only, or nothing at all.
 
JohnWilson

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Most of the implant design libraries from 3rd parties are not LOCKED that is the problem.

Any 3shape specific library MADE for version 2015 must be tied to a FDA cleared Ti base. If so they all have hard stops built into the DME.

All other "pending" FDA clearance bases do not and the user must do a "work around" to use them with the software.

Until 3shape FORCES us all to be on one version "newest" of the software none of their system can be compliant in my eyes. Which will never happen.

The sad truth is that all of this should be on the Dr's shoulders and not the lab in my opinion. Make it by hand, make it by machine, if its wrong its wrong. Who is at fault now? More finger pointing and nothing more is really being done to improve the reason why we even have to worry ourselves with this BS.

I look at this and think to myself

1) Its pretty obvious if I am angle correcting an abutment 60* its probably going to fail
2) If the abutment is in spec and 6mm tall but I put a 20mm tooth on top of it who the hell is regulating that
3) How do telescopes get classified?
4) What if we rename all abutments screw retained crowns with Veneers?
5) How about M/D width pretty sure no hard stops for that
6) IF there is a regulation about milling prefab blanks why the hell would the blank manufacturers make the blank size IMPOSSIBLE to mill outside of said spec?
7) Who os going to make money on these regulations and who is going to benefit from it?

OK its Friday and these are just a few of the things rattling around my head today, enjoy the weekend
 
JMN

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Most of the implant design libraries from 3rd parties are not LOCKED that is the problem.

Any 3shape specific library MADE for version 2015 must be tied to a FDA cleared Ti base. If so they all have hard stops built into the DME.

All other "pending" FDA clearance bases do not and the user must do a "work around" to use them with the software.

Until 3shape FORCES us all to be on one version "newest" of the software none of their system can be compliant in my eyes. Which will never happen.

The sad truth is that all of this should be on the Dr's shoulders and not the lab in my opinion. Make it by hand, make it by machine, if its wrong its wrong. Who is at fault now? More finger pointing and nothing more is really being done to improve the reason why we even have to worry ourselves with this BS.

I look at this and think to myself

1) Its pretty obvious if I am angle correcting an abutment 60* its probably going to fail
2) If the abutment is in spec and 6mm tall but I put a 20mm tooth on top of it who the hell is regulating that
3) How do telescopes get classified?
4) What if we rename all abutments screw retained crowns with Veneers?
5) How about M/D width pretty sure no hard stops for that
6) IF there is a regulation about milling prefab blanks why the hell would the blank manufacturers make the blank size IMPOSSIBLE to mill outside of said spec?
7) Who os going to make money on these regulations and who is going to benefit from it?

OK its Friday and these are just a few of the things rattling around my head today, enjoy the weekend
#7 is the key. Qui Bono. It's the Standard Oil method again. Regulate the little guys out of the market.
Making sense to those who know what's going on is not part of their concern. Setting up for good marketing to those who don't is.
The market is being shaped. The question is can we find ways to fit into that shape with the shaper.
 
Linda Saylor

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Hi Linda:
You mentioned 3shape have their implant software approved...I have heard that all they did was block non FDA approved library files from their software. Please correct me if I am mistaken, but I do not think that they are approved by the FDA, nor is any other software as you mentioned besides Cerec. When I mean approved that their entire software is approved by the FDA which I believe is not. I believe the only way the FDA will approve a system with this software or any others is if it is a complete system such as Cerec. I know ZZ has exocad under the covers of their software and has tried for several years to get their parts FDA and does not have it (over 2+ years later) and the same with Origins and I am sure there are others.

: K152078 Trade/Device Name: 3Shape Implant Studio™ it was approved 01/04/2016. This is not the 3Shape Dental Design CAD designing software you are thinking unfortunately. My point was, 3Shape has been through the 510k clearance process for software and is well aware of what it takes.
 
keith goldstein

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Thanks ...this is a FDA approval for their surgical guide software only (similar to a simplant, nobel guide, codiagnostic) but this does not cover fabrication of crown or other implant restoration. They do not have FDA approval for this nor does anyone else except for Cerec.
 

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