Abutment fixture(s)

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[NDLMilling]

nice looking fixtures!
-Greg

 

[DMC]

I know, right? Cool idea.

Greg, you milling interfaces yet, or what?

 

[JohnWilson]

I would bet there are less than 100 labs in the US milling there own interfaces. Come to think of it I bet 100 is high.

 

[DMC]

I think you are right John.

It was harder than I first thought, but we are doing it now all day long and having success.

I have only seen One lab doing it in Ca but never saw any finished products, and heard of a few more. (excluding Glidew3ll).

I think we are going to buy another Metal mill before the Summer hits. It's fun and profitable, but very technical and challanging.

 

[JohnWilson]

I think you are right John.

It was harder than I first thought, but we are doing it now all day long and having success.

I have only seen One lab doing it in Ca but never saw any finished products, and heard of a few more. (excluding Glidew3ll).

I think we are going to buy another Metal mill before the Summer hits. It's fun and profitable, but very technical and challanging.

Mark my words the biggest players in this industry are not the ones that will eventually be visited by FDA.

The quote you posted in the other thread has been around for a while but truthfully when I first entertained milling interfaces I did contact FDA and the FEES to become compliant were stagering. I found it to be a quite daunting task, and gave up with the notion for now.

Like any other regulatory system in place its only as important as the enforcement. Like many things in this life if the feds don't see it as important it will only become important and enforceable when the people with money in this industry lobby for it to control the competition.

Just some musing I have on the topic.

 

[brayks]

Mark my words the biggest players in this industry are not the ones that will eventually be visited by FDA.

The quote you posted in the other thread has been around for a while but truthfully when I first entertained milling interfaces I did contact FDA and the FEES to become compliant were stagering. I found it to be a quite daunting task, and gave up with the notion for now.

Like any other regulatory system in place its only as important as the enforcement. Like many things in this life if the feds don't see it as important it will only become important and enforceable when the people with money in this industry lobby for it to control the competition.

Just some musing I have on the topic.

Interesting post John.
Its amazing to me that there is no definitive answer on the FDA approval issue relative to abutments.

I looked into getting FDA 510(k) approval for pre-milled ti abutment blanks last year before we decided to go with the NT-Trading blanks which have FDA clearance.

It was going to cost somewhere around $40K to work with a respected international consultant I know and go through the process.

The word going around at the time was that milling centers producing custom abutments were going to have to have FDA approval for their process as well as using FDA approved blanks.

I asked the consultant if he had heard about the requirement and he said not and would be surprised if it was the case.

He have me the telephone number for a gentleman he know in the FDA who was in this area and said I should call him.

Well I did, and surprisingly enough he picked up the phone and I had a fairly lengthy conversation with him. He adamantly said that was not the case and said the FDA had nothing to do with the process of manufacturing the end abutment just that the blank had to be FDA approved.

Actually he wasn't all that pleasant as I kept asking him, basically the same question as I wanted to make sure we were both clear.

Just relating my experience FWIW...

 

[JohnWilson]

Interesting post John.
Its amazing to me that there is no definitive answer on the FDA approval issue relative to abutments.

I looked into getting FDA 510(k) approval for pre-milled ti abutment blanks last year before we decided to go with the NT-Trading blanks which have FDA clearance.

It was going to cost somewhere around $40K to work with a respected international consultant I know and go through the process.

The word going around at the time was that milling centers producing custom abutments were going to have to have FDA approval for their process as well as using FDA approved blanks.

I asked the consultant if he had heard about the requirement and he said not and would be surprised if it was the case.

He have me the telephone number for a gentleman he know in the FDA who was in this area and said I should call him.

Well I did, and surprisingly enough he picked up the phone and I had a fairly lengthy conversation with him. He adamantly said that was not the case and said the FDA had nothing to do with the process of manufacturing the end abutment just that the blank had to be FDA approved.

Actually he wasn't all that pleasant as I kept asking him, basically the same question as I wanted to make sure we were both clear.

Just relating my experience FWIW...

I would be interested in his contact info, this info is totally contrary to what I have found to be true.

Glad to have you posting the new Axsys website looks great!

 

[brayks]

Thanks John. Yes, I know what you mean. I was quite surprised and even more confused after our conversation.
The FDA rep was really getting a little annoyed with me as he kept repeating that they do NOT approve process. I would then repeat myself, explaining the situation and the common belief of the requirement to which he would repeat "we do not approve process". It was like: "are you deaf Steve? I said; we do NOT approve process".
I still shake my head thinking about our conversation.
Anyway, I will send you a PM with further info.
Best
Steve

 

[DMC]

John.....

You are missing the party buddy!

I think you have had too much recent contact with Mark Jackson, right?

Something rubbed-off onto you too now?

(Chicken)

I can't wait for my second Ti mill to arrive!

 

[JohnWilson]

John.....

You are missing the party buddy!

I think you have had too much recent contact with Mark Jackson, right?

Something rubbed-off onto you too now?

(Chicken)

I can't wait for my second Ti mill to arrive!

Perhaps, anyhow I am not looking to mill only the tops anyhow and god knows there is a lot more to milling interfaces than most people understand.

I know what I am good at and being an engineer isn't one of them. At least not now

I have been shopping for a new REAL capable mill for things I never dreamed I would consider to fab in-house. I just don't have the knowledge passion or drive to purchase a non industry specific mill and convert it to fit my needs. I need a turnkey mill that will do bars, and interfaces PRECISELY. I want to plug it in and GO for that I understand I pay a premium.

The fact that a CLASS 2 device is regulated leads me to believe that there is plenty of misinformation on this topic. The fact that the pre-fabbed blanks need to be FDA cleared is very telling.

Still doing my homework.

 

[brayks]

Whoops!!

Did not realize I am posting in a vendors thread!!

So sorry! Terrible manors!

What I meant to say is....ah, go buy an axsys mill.

Yeah, thats it.

Really?

 

[DMC]

You have an awesome mill for the $$.

Your group has amazing experience.

What could I possibly say bad about you guys????!!!

Top Notch stuff! It is just another way to skin the cat. ??

I did not know about the Versamill when I bought my first HAAS.

Most people will never buy a HAAS because it is just too darn complicated to make a Dental version yourself, and HAAS will certianly NOT help you. I know this for a fact! LOL

Good luck with the new year!! Maybe I end up with a versamill One day??

 

[DMC]

Hey, do you listen to Howard Stern also???

I love that show, and he often plays that little bit from Curley...."I keep trying to think, but nutin'happens!"

 

[KentPWalton]

The fact that a CLASS 2 device is regulated leads me to believe that there is plenty of misinformation on this topic. The fact that the pre-fabbed blanks need to be FDA cleared is very telling.

Still doing my homework.

There is a lot of misinformation on this topic.

 

[JohnWilson]

There is a lot of misinformation on this topic.

Share what you know to be true Kent

 

[KentPWalton]

Share what you know to be true Kent

Implant manufacturers have spent all this time jumping through all of the FDA hoops of getting all the R and D done and tons of testing and validations, then there is A LOT to it! Including lots of dollars might I add. The tolerances done by screw machines are much tighter than that of a desktop mill can give you. The engineers have set specific ranges ( +/- 2-3 microns) for the parts to be made and go through a rigorous quality inspection for every part made. Many desktop mills cannot mill out an interface because it falls outside the manufacturer's tolerances. I am just very weary of trying to mill out an interface due to the tight tolerances of an implant because the FDA might show up on the doorstep one day and shut you down or fine you or whatever they can do.

 

[brayks]

Hey, do you listen to Howard Stern also???

I love that show, and he often plays that little bit from Curley...."I keep trying to think, but nutin'happens!"

Hey ***,
I haven't listened to Howard in quite a while. When I'm driving, if I'm not listening to a tune I'm trying to learn for the band, I'm listening to talk radio. Boy am I gettin' old...

 

[DMC]

Implant manufacturers have spent all this time jumping through all of the FDA hoops of getting all the R and D done and tons of testing and validations, then there is A LOT to it! Including lots of dollars might I add. The tolerances done by screw machines are much tighter than that of a desktop mill can give you. The engineers have set specific ranges ( +/- 2-3 microns) for the parts to be made and go through a rigorous quality inspection for every part made. Many desktop mills cannot mill out an interface because it falls outside the manufacturer's tolerances. I am just very weary of trying to mill out an interface due to the tight tolerances of an implant because the FDA might show up on the doorstep one day and shut you down or fine you or whatever they can do.

Well, so much for Kent sharing/quoting any real rules and regulations.

(Got a link to what you think you know? Source please.....)

Only spouting out about ?? Dunno?

Abutments and bars mill just fine with the correct mill, tools, and CAM (NOT turning!)

How the heck do you turn a bar anyways? LOL

Certianly mucho mis-information indeed!

You do NOT need a Swiss turning center to make an abutment.

We are not making screws and implant analogs by the Thousands. Yes, those are turned.

The Ti interfaces for glue-to are also turned. ONLY because they are making thousands of the exact same parts over and over. The Swiss turning is soooo much more efficient when doing this mass production of identical parts. Has nothing to do with the accuracy at all Kent, but rather efficiency and keeping overhead down to make a profit.

Many many labs all over the planet mill abutments and bars, and life goes on.....with or with your approval. LOL

Custom abutments are most commonly NOT turned. Setting up a Swiss mill to make anything takes so much time! Only worth it for long run cycles with high production of many many parts.

??

I am sure this is what you meant to say. Right?

 

[primus]

Post a link to some REAL info, or copy paste. Why is this so hard?

Otherwise, you guys are just talking trash here!

Both John and Kent.

I think you guy really do not know anything, but only speculation at this point.

Right? (Yes)

One of a kind, custom abutments and bars are NOT needing FDA approval.

Never has been in the past, and not now.

Labs make abutments for years and years.....

This was clearly printed in LMT with the correct wording taken directly from the FDA.

The end......., unless you can prove me wrong in Black&White.

Show me!