FDA & milling abutments in house

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Jurim

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Is this where we are going within the US market?



FDA Alert - Labs not permitted to use CAD/CAM for in-lab milling of most abutments

When FDA began studying the use of CAD/CAM in dental laboratory technology, the FDA’s initial focus was on angulation and the implant/abutment interface. FDA ultimately made clear statements that anyone making the implant/abutment interface is a "manufacturer" as such must obtain 510(k) clearance to do so.

That still did not answer the questions about the “tooth end” of the abutment, the abutment collar/post. Sometime later FDA ultimately stated a dental laboratory may mill the collar/post as long as the dental laboratory follows the manufacturer's FDA cleared instructions.

Now, nearly two years later, there is still only one manufacturer that has obtained FDA clearance for their in-lab CAD/CAM milling instructions for their abutment collar/post. FDA’s recent communications have alerted us to what this means for dental laboratories:

· With the exception of the abutments of the one manufacturer who has FDA cleared instructions*, dental laboratories may not CAD/CAM mill the abutment collar/post including the Ti-Base type “abutments blanks”.
· Abutment blanks may only be hand-milled.

*Sirona CAD/CAM System (K111421)


Currently FDA enforcement efforts seem to primarily consist of sending compliance letters to manufacturers as their website marketing is brought to FDA’s attention.

NADL monitors FDA regulatory activity on an ongoing basis. As a service to our membership; we strive to keep NADL Members informed on current regulatory developments. NADL Members are encouraged to contact the NADL office as a resource for assistance with your regulatory questions.
 
JMN

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What are they going to do, fine every lab/manufacturer? More likely they'll try to paper everyone into submission and then maybe make a few examples if they can find weak enough opponents.
 
smilesatgalleria

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This is very bad thing in US market which affect the policy of dentist and their lab also. Hope that good result comes out after FDA study.
 
doug

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Bennett Napier made some comments about this issue at a meeting in south Florida 2 weeks ago. It has a basis in fact.

BTW, if you are not a member of the NADL, join. This is what they do for you. This information is important. Better to get it from the source than hearsay
 
JKraver

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Bennett Napier made some comments about this issue at a meeting in south Florida 2 weeks ago. It has a basis in fact.

BTW, if you are not a member of the NADL, join. This is what they do for you. This information is important. Better to get it from the source than hearsay

Removeable guy don't care all that much about in house milling, but I get your point. I am more interested in FDLA. Both are just money grubbers IMO.
 
Gru

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Bennett Napier made some comments about this issue at a meeting in south Florida 2 weeks ago. It has a basis in fact.

BTW, if you are not a member of the NADL, join. This is what they do for you. This information is important. Better to get it from the source than hearsay

Doug, please clarify, "this is what they do for you" statement. Do you mean they lobby for these FDA changes?
 
ChrisBWJ

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To “fabricate the ceramic or metal abutment via cadcam” in the lab requires 510(k) clearance.

Sirona indeed has a 510k on their system to produce custom implant abutments (K111421).

A 510k on just the Titanium bases or millable blanks is not enough. There are correction angle maximums in both cases that have to be enforced, usually done in software, but not necessarily. This is why there have been some issues with the 2014 vs 2015 3Shape CAD software. Changes were made in 2015 to help with 510 compliance of a manufacturer's part library. There are zirconia types and cements that are part of the fatigue tests that have to be used for the hybrids.

Implementation of a Quality Management System (QMS) and Good Manufacturing Practices (GMP) are part of the requirements of maintaining the 510k clearance and the ability to market abutments once it has been achieved.

I suspect greater scrutiny is coming to the US Market. What that will look like in 12 months, I couldn't say for sure.
 
doug

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Doug, please clarify, "this is what they do for you" statement. Do you mean they lobby for these FDA changes?
The NADL removes the veil of BS from all the rumor mills by providing you accurate information on the happenings in the industry. This is not a new piece of information, they just had to wait until it was more solid before notifying all of us. Anyone with a mill has been able to mill tops for Ti bases. Now the FDA has guidelines in place to protect the patient. Evidently Sirona has know about this and has worked towards compliance. They also can easily afford to pay the FDA registration fee, which is about $2900.00 this year and going up annually. I can't afford that so I outsource. This is information that the NADL can provide for you.
 
JKraver

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The NADL removes the veil of BS from all the rumor mills by providing you accurate information on the happenings in the industry. This is not a new piece of information, they just had to wait until it was more solid before notifying all of us. Anyone with a mill has been able to mill tops for Ti bases. Now the FDA has guidelines in place to protect the patient. Evidently Sirona has know about this and has worked towards compliance. They also can easily afford to pay the FDA registration fee, which is about $2900.00 this year and going up annually. I can't afford that so I outsource. This is information that the NADL can provide for you.
Are there fines/sanctions in place? If not why don't you just mill until they do?
 
rkm rdt

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To “fabricate the ceramic or metal abutment via cadcam” in the lab requires 510(k) clearance.

Sirona indeed has a 510k on their system to produce custom implant abutments (K111421).

A 510k on just the Titanium bases or millable blanks is not enough. There are correction angle maximums in both cases that have to be enforced, usually done in software, but not necessarily. This is why there have been some issues with the 2014 vs 2015 3Shape CAD software. Changes were made in 2015 to help with 510 compliance of a manufacturer's part library. There are zirconia types and cements that are part of the fatigue tests that have to be used for the hybrids.

Implementation of a Quality Management System (QMS) and Good Manufacturing Practices (GMP) are part of the requirements of maintaining the 510k clearance and the ability to market abutments once it has been achieved.

I suspect greater scrutiny is coming to the US Market. What that will look like in 12 months, I couldn't say for sure.


So , how does this affect the milling of screw-retained FCZs (cemented to pre-fabricated Ti inserts) and the like?
 
doug

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Please explain how FDLA and NADL are money grubbers? They are both associations that are for your protection and support. They provide necessary educational opportunities and navigate the often complicated issues that face laboratories that are run as a business. I support both associations and feel that I get much more from them than the cost to me annually. I also happen to be a board of director for the Florida board so i get to see the money grubbing side you speak about. It doesn't exist. I pay my way to all meetings I attend, I put in my own time to make sure that the members get what they are promised, I have been on the outside looking in. This view of our industry is a lot more positive, especially when you have a network of people to work with.
 
Affinity

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Does anyone really listen to the FDA anyways? We certainly dont regarding other things we consume.

This sounds like, it would be against the 'law' to mill a Ti abutment on say, a motion2 , unless your lab is 510 compliant.. meaning youve paid the fda $2900/yr.

So ultimately.. what the NADL or FDA or ABCD is saying.. is that every milled abutment, bar, etc. is being manufactured, ILLEGALLY, currently unless you are using sirona to mill it.....????? What about nobel? What about panthera, outside the US?

BirdDeal
 
PearlZ

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i think panthera has a 510k and it would surprise me that nobel doesnt.

implant manufacturer with 20 years and the industry standard has no 510k ... not likely.

vulcan has one.

i dont think we do though. and that's ok, i just won't offer implant services to USA customers. easily done. less headaches for me.
 
PearlZ

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Joe Blow however, with his basement lab and his el cheapo Roland with no permission to make implants - that's a big deal breaker.
 
JohnWilson

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As I understand it the software manufactures (3shape and others) are making this a non issue with newest DME's. I think there was pressure on them to make this happen. I do not believe anyone is stating you cant mill the tops, what it is saying the software that allows you to do it must be compliant to the point that the angle and height to the TOP of the restorations is in accordance to the manufactures recommendation.

The fact that you can still buy a UCLA and hand wax the thing at a 70* acute angle to the fixture makes no sense to me but milling something way more precise is now outlawed??? Have you ever read the instruction for UCLA's??

Its not a luxury to have good GMP's in place its the law, being able to show how you have produced a restoration with good service logs and calibration logs for your equipment along with logs with LOT and reference numbers on your cad bases will indeed be the bare minimum you should be doing. Having a specific protocol for your cementation and documentation as to how you are consistently doing the same thing that matches the manufactures description for what you are doing. Making specific notation when and if you change cement and keeping track of any new updates on the material as well.

We will need more info on this for sure, I really can't see that EVERY lab would need to get 510K cleared. The cost alone as well as the time to get compliant would force many labs out of business. I can guarantee that the Feds do not want that **** storm>

If you are using a FDA cleared part ( cad base or stock abutment) and milling the top today you are not a criminal

The end.
 
Affinity

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Now, nearly two years later, there is still only one manufacturer that has obtained FDA clearance for their in-lab CAD/CAM milling instructions for their abutment collar/post.


I guess I read it wrong, the wording is that you CAN mill the abutment top, IF you follow the MFG IFU... Still, the only one that has them in place is sirona..

Maybe I dont understand the whole point of the post if OTHER milling centers are obviously compliant, or even more compliant than sirona..

The fact that you can make a piece of $hit by hand and not on a computer shows how clueless the people making these 'laws' are.
 
2thm8kr

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Certainly the implant companies are lobbying for this.
As mentioned above, some dolt with no real training can wax/design and cast a ULCA, no problem, regardless of how poorly placed the implant is in the first place.
Using a Ti base that was manufactured on a multi axis Swiss lathe and making a top whether pressed or milled is somehow less accurate or more dangerous to
the patient? Please!!:rolleyes:

This is about money and politics more than anything else. The FDA has people with experience and common sense working on this? I highly doubt it!
Implant companies have been gouging the industry for years and their plan is to continue to do so, no matter what small business they bury in the process.

If the FDA had a way to enforce this, they would be doing it already. It's going to take a committee, to have some meetings about when they are going to plan
on coming up with regulations, then a committee to decide the penalties, etc., etc.. This industry will move in a different direction before they are ready and
the hand piece or spindle will keep turning.
 
2thm8kr

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The NADL removes the veil of BS from all the rumor mills by providing you accurate information on the happenings in the industry. This is not a new piece of information, they just had to wait until it was more solid before notifying all of us. Anyone with a mill has been able to mill tops for Ti bases. Now the FDA has guidelines in place to protect the patient. Evidently Sirona has know about this and has worked towards compliance. They also can easily afford to pay the FDA registration fee, which is about $2900.00 this year and going up annually. I can't afford that so I outsource. This is information that the NADL can provide for you.
So my question is, what are the NADL or FDLA or any other supposed advocate of the dental tech industry doing to combat this B.S.?
I can get the information myself rather than waiting for them to publish it somewhere.
 
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