JKraver
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What about exocad?
What about exocad?
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.
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.
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.
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.
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.
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?
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.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
#7 is the key. Qui Bono. It's the Standard Oil method again. Regulate the little guys out of the market.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
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.