FDA 510K Implant abutment clearance

[sonlab]

I am sure Dentists know that milled interfaces are more accurate and better for the patient- The main issue I see here is if a patient sues a doctor over issues with their implant if the lawyer asks for proof of FDA 510(k) components used- that is where everyone gets screwed

 

[grantoz]

i thought the law states the person responsible is the dentist they are the ones who give the thumbs up if its the correct appliance or not .they are the ones who are responsible for all the checks and balances .If they ask you is everything fda compliant and you say its not and they still place it then they are in trouble.the only time we are in the 5hit is if we lie and say its fda compliant and its not.We can make anything we like its up to the dentist to decide what they do with it.i just think we are taking on to much responsibility as usual its up to guys who get payed the big dollars to check all this stuff if they truly want fda everything it has to cost them.Many dentist over the years have used bovine products etc with no fda and think nothing of it they treat it a bit like a joke.

 

[Tom Moore]

Why would anyone build a custom dental devices for a dentist that will except it not being done under and according to FDA guidelines?

Also at this time of the year when we are slammed with work would anyone have the time to drag a post like this to 4 pages?

 

[JohnWilson]

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

You say funny stuff from time to time but this one really made me laugh out loud!

Its so silly we are all looking for real world truths as it relates to this and even with the work/letter NADL put out many of us are still looking for clarity and ways around the inane law/laws. I thought their description was clear as mud.

Makes me want to get to that little island and forget about teeth forever.

 

[vurban210]

Why would anyone build a custom dental devices for a dentist that will except it not being done under and according to FDA guidelines?

Also at this time of the year when we are slammed with work would anyone have the time to drag a post like this to 4 pages?

Wow, so much concern for everyone else, you are such a nice guy. But I am left to wonder, if you are so darn busy then how do you have time to worry about what everyone else is doing?

 

[brayks]

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

http://nadl.org/sl_files/487CEA77-5056-A04E-37A0DDED9A8D218E.pdf

 

[brayks]

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.

My understanding is that the labs, milling centers, etc. are NOT required to obtain these clearances IF they utilize pre-form blanks who have the proper FDA clearances. Such clearances are now rumored (since I am not aware of any published FDA statements clarifying the matter) to include FDA cleared work instructions that are verified to include the use of stated CAD or CAM software with "hard-stops" that occur when a CAD or CAM software processes a custom abutment case with their pre-form blank that falls outside of the safe usage parameters of a given manufacturers implant platform.

I have spoken to very many consultants and quickly learned that although there are very good ones; very many consultants are like excuses... One really has to vent them properly to make sure you do get a good one.

Just my couple of cents...

 

[Linda Saylor]

My understanding is that the labs, milling centers, etc. are NOT required to obtain these clearances IF they utilize pre-form blanks who have the proper FDA clearances. Such clearances are now rumored (since I am not aware of any published FDA statements clarifying the matter) to include FDA cleared work instructions that are verified to include the use of stated CAD or CAM software with "hard-stops" that occur when a CAD or CAM software processes a custom abutment case with their pre-form blank that falls outside of the safe usage parameters of a given manufacturers implant platform.

I have spoken to very many consultants and quickly learned that although there are very good ones; very many consultants are like excuses... One really has to vent them properly to make sure you do get a good one.

Just my couple of cents...

Only problem is there is only one software so far that is approved..... So they have a strangle hold on all the labs. It appears now, that in order to get around purchasing new software labs must become an FDA certified milling center. If they already hold 13485 certification it shouldn't be to hard but again it comes down to a good consultant to help you achieve that. Does anyone have someone they would recommend?

 

[doug]

Just a thought today about this whole issue The FDA directive is going to force the surgeon or perio guys to do it right from the beginning. Historically, there has be a blowback about using guided surgery because they might lose an opportunity to do the case because of an increased fee to the patient. God forbid they provide the piece of the plan that does them the best option without a charge. Now they have an out. "Mr so n so, FDA guideine require that I have a guide to place the implants in the best possible location. With that there is an additional fee for the guide. Also, I can tell you before we start whether I will need to augument the bone for best result and you will know what that fee is also.' There it is, the blame falls squarely on, who else, Obama. I expect this, over time, to be the best thing that can happen to us as we can do the work we know needs to be done at a higher level and the time saved not having to babysit a case will result less time spent on each case. Oh yeah, I'm raising my fees next month, too.

 

[brayks]

Only problem is there is only one software so far that is approved..... So they have a strangle hold on all the labs. It appears now, that in order to get around purchasing new software labs must become an FDA certified milling center. If they already hold 13485 certification it shouldn't be to hard but again it comes down to a good consultant to help you achieve that. Does anyone have someone they would recommend?

I have found these two companies to be quite good:

• http://www.safelinkconsulting.com/
• http://www.emergogroup.com/services/united-states

 

[Linda Saylor]

Thank you! I will look into those. I am sure the FDA will give people time to comply with the new requirements.

 

[RJS8669]

So...

I'm going to be the guinea pig. Set it up yesterday to start the ball rolling on getting FDA-compliant. I already have Biodenta's wet mill, so I'm going to piggyback off of them. All I know right now is I will be filing with the FDA and then setting up a QM system for tracking purposes. I will write posts during the process so that those interested get a little more insight into the process. I'm closed next week, so we are going to start Jan. 5.

 

[Linda Saylor]

So...

I'm going to be the guinea pig. Set it up yesterday to start the ball rolling on getting FDA-compliant. I already have Biodenta's wet mill, so I'm going to piggyback off of them. All I know right now is I will be filing with the FDA and then setting up a QM system for tracking purposes. I will write posts during the process so that those interested get a little more insight into the process. I'm closed next week, so we are going to start Jan. 5.

Thank you so much for allowing us all to share in what will be trying and enlightening process!!!!

 

[Zubler USA]

This topic got brought up again for me recently so I did some research and have seen many of the same posts mentioned on this forum. I also ventured over to the FDA website and started reading...a lot! Anyone done that yet? I also re-read the posts from the different industry groups after going to the FDA website. Once re-read, light was shed on many of their interpretations. Ultimately, none of you are going to get accurate detail without speaking directly to the FDA or an attorney you can trust. But ultimately, I came to the conclusion that laboratories are going to have to get FDA clearance to use CAD/CAM machines to mill abutments from the collar down. Ironically you can still cast or Hand mill without FDA clearance. What is unclear are the requirements needed from the manufacturers. If you believe what was posted on some of the websites, those of you that have already invested in machines are going to have to hope and wait for your manufactures to comply before you can. However, I am not sure this is the case. More will come out soon. Manufacturers are all probably swarming the FDA right now. Chicago will be all about this. Go if you can.

 

[grantoz]

so if you use an approved interface you are ok i think that is what most are doing anyway.

 

[Zubler USA]

so if you use an approved interface you are ok i think that is what most are doing anyway.

Not so sure, Let me predicate this by saying, I may be incorrect in my interpretation. Which is why it is so important for you to do your own homework. But it seems FDA compliance in the form of traceable process control, may extend beyond the interface. Either way, you are definitely better off using a per-approved implant/interface system, but FDA approval may still need to be obtained on an individual basis at the laboratory level provng you have controls in place that guarantee safety and quality.

 

[cadfan]

Implant Refugees are welcome too.

 

[Beatrice]

so if you use an approved interface you are ok i think that is what most are doing anyway.

You are correct, BUT
Only 1 company offer approved block at the moment.

Otherwise you can outsource your abutment to milling center that mill the interface and are approved by the FDA.
And there are few.

Right now if FDA apply what they say we are talking over +/-90% of abutment milling center that would have to stop production until they get their FDA approval.

 

[Zubler USA]

You are correct, BUT
Only 1 company offer approved block at the moment.

Otherwise you can outsource your abutment to milling center that mill the interface and are approved by the FDA.
And there are few.

Right now if FDA apply what they say we are talking over +/-90% of abutment milling center that would have to stop production until they get their FDA approval.

What about K105203 & K150669 & K102804? Do these apply to our discussion? Not certain.. but it is interesting to see that this information is freely downloadable at the FDA website (for free). So, instead of believing the manufacturer/dealers (Those with an interest). Go take a look for yourself. Just go to the FDA Website.

 

[Linda Saylor]

What about K105203 & K150669 & K102804? Do these apply to our discussion? Not certain.. but it is interesting to see that this information is freely downloadable at the FDA website (for free). So, instead of believing the manufacturer/dealers (Those with an interest). Go take a look for yourself. Just go to the FDA Website.

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.