FDA 510K Implant abutment clearance

Linda Saylor

Linda Saylor

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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.

That was exactly my point. No one but Cerec has approval. However, 3Shape has experience in the process obviously and if they chose to do it they could was all I was trying to say.
 
Gru

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I believe Biodenta not only has 510k clearance for abutments, but has a way of clearing them for in-house milling with their mill and software.
 
keith goldstein

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I believe you are correct regarding Biodenta. They also offer an implant too. This is going to be one of the futures- labs selling implants along with everything else, including small labs since the loyalty of the implant companies will largely be for a select few labs.

Linda thanks for the clarification - I spoke to one of their competitors regarding this "fda approved" system which would be just like Cerec and this vendor who sells through distributors said they would have their distributors go through FDA on the entire system. 3Shape absolutely could do this just takes money and time and maybe they will be forced to because of FDA requirements...lets hope not since this would not be good for any of the open architecture cad/cam suppliers and especially the small and medium size labs.
 
lcmlabforum

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So basically, any implant manufacturer FDA cleared to produce implants, would be cleared to fabricate
custom abutments by milling. No matter how badly they fit or may break, at least it is legal, right?
Just saying . . .
LCM
 
keith goldstein

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Atlantis has numerous FDA 510k's for their custom abutments for different systems-
http://www.510kdecisions.com/product_codes/index.cfm?fuseaction=companies&product_code=NHA

What I have learned in going through an FDA process (for an implant) is that there are different tests required based on the type of implant and abutments you are providing.
If a stock angled abutment is part of the submission (versus submitting a straight abutment) then they go through additional static and dynamic stress testing which you may read that a company goes through 5 million cycles of stress testing to determine when they will break.

So given that a custom abutment is often angulated or not considered a "straight" abutment one would assume that a custom abutment would go through the same static and dynamic stress testing testing that a angled abutment would go through.

The issue with fit is another story since this requires extensive engineering, tolerance testing, fit testing, engineering drawings, various calculations to determine tolerance and fit to demonstrate that the part is cross compatible with an existing implant. That is part of the 510K submission for cross compatible abutments and would be the same for a custom abutment. So how they fit should be accurate enough if they are FDA approved.

Now other issues occur post production regarding the testing of the tolerance and fit of the custom abutment part and therein lies the mystery - what true testing goes on to ensure that the milled custom abutment has the correct tolerance and fit based on the original CAD drawings of the 510K submission for the connection? Companies do not do this because it requires metrology equipment (which costs a lot of money but not really) and time to do this testing to ensure accuracy and fit and accepted tolerances of the part. At DESS, since we make stock parts, we do this on every batch of parts with two different metrology systems, testing a sample of the parts to ensure they fall within a 10-20 micron accuracy of the original CAD drawings.



This way we know that if the parts don't fall into that range we start over making a new batch and destroy the others.

This is why the premilled interface titanium blocks are the future for this business because the manufacturer can test and validate the fit, tolerances, and cross compatibility prior to sending to their clients.
Health Canada and FDA are the two regulatory bodies who require the tolerance, fit, and cross compatibility testing as part of the submission. CE does not require this.

We have Health Canada and pending FDA.

In other words if you are working with a supplier of any abutment that does not have Health Canada and or FDA then you have a much higher chance of running into the fit issue, tolerance issues, increase of micro movements, and screw loosening or breakage issues.

This is what caused this entire crackdown to begin with. A few bad apples making aftermarket abutments that were creating failures of implants (heard from a consultant that wrote the specs on these regulations). Another topic for another day.
 
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lcmlabforum

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Thanks Keith for clarifying. Makes good sense too.
LCM
 
eyeloveteeth

eyeloveteeth

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FDA compatibility has 2 parts (not including all the ISO stuff too). one is the machining and what not, the 2nd is if it pairs to the compatible brands. Typically the machining is easy as hell. The ability to prove that it fits an FDA approved implant is a bit harder and is what has caused a lot of people to lose or expire their 510Ks over the years. It is also why it takes so long for the application process to go through today.

on one hand, if you had access to the OEM implant design/paperwork and presented it as a "X" std deviation in production from the "base" then it's easier - to be 3rd party and to do this is virtually impossible as the time to get it done vs simply having access to the original implant schematic.

Massive kudos to Keith and all the other 3rd party companies finally crossing the finish line.


Keep in mind, this is also why some companies with their 510k years ago cannot continue to use it as the main implant brands rebrand and rename their implants. This forces the 3rd party companies to reissue/reapply and with even more stringent requirements than 2008, it's a wonder that anyone has gotten it done.
 
corona

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FDA compatibility has 2 parts (not including all the ISO stuff too). one is the machining and what not, the 2nd is if it pairs to the compatible brands. Typically the machining is easy as hell. The ability to prove that it fits an FDA approved implant is a bit harder and is what has caused a lot of people to lose or expire their 510Ks over the years. It is also why it takes so long for the application process to go through today.

on one hand, if you had access to the OEM implant design/paperwork and presented it as a "X" std deviation in production from the "base" then it's easier - to be 3rd party and to do this is virtually impossible as the time to get it done vs simply having access to the original implant schematic.

Massive kudos to Keith and all the other 3rd party companies finally crossing the finish line.


Keep in mind, this is also why some companies with their 510k years ago cannot continue to use it as the main implant brands rebrand and rename their implants. This forces the 3rd party companies to reissue/reapply and with even more stringent requirements than 2008, it's a wonder that anyone has gotten it done.
 
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Hey everyone,
I just started working at my current lab a little over a month ago, and I'm currently tasked with sorting out the mess that is our implant and CAD departments. We have our implant work on a standalone system running 3shape 16.4.0, and the other computers doing general CAD work are on another server running 17.2.1. Ideally, I'd like to combine them all so that anyone can design anything from anywhere. Today, my implant manager told me that the reason they hadn't upgraded past 2016 was that he thought they couldn't because of something to do with FDA approval on certain implants. This sounds vaguely familiar, but I've been out of the 3shape game for a while. Is this still a thing?
Thanks so much for your help!
 
DESS-USA

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yes this is a thing. the reason he is using an earlier version of 3shape is it did not require the use of library files that are FDA approved and using FDA approved components. If he updates to 2018 then the only library files he can use are from companies that have FDA approved libraries AND ti bases/components for that specific system. There are some companies that have not complied with FDA and will provide you a library file for 3shape and modify some of the settings so their library files will work.
Call me if you need further clarification etc.
 
Beatrice

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Even worst, if you do design bar, even if bar do not need FDA at the moment in USA to be sold, 3shape will block you from using bar software since it use the same config file as your abutment software, this is a HUGE flaw in 3shape that they never address.
 
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Medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application.

Edited: removed link to blog.
 
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CoolHandLuke

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Medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application.

Edited: removed link to blog.
thank you for the participation. we don't allow links to your own site or blog; in this particular case as you probably arent a dental lab but rather a consulting service for manufacturers seeking 510k's, i'll leave the post up, but remove the link. its easy enough to type in to google i3cglobal to find your site. lets leave it there.
 

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