FDA & milling abutments in house

rkm rdt

rkm rdt

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Not only are you now liable,you'll be taxed on it.

Wait till Hillary tacks on a Carbon tax as well.Deal
 
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RJS8669

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So labs are now liable for poorly placed implants?
Am I the only one that thinks this is total Bullsh1t!!?
This is absurdity at it's finest. The government protecting the interests of global corporations at the expense of small business once again.
Hope you can find the right combination of condiments to choke down this steaming pile!
To me, the crazy thing is that it seems you can do whatever you want to in order to correct an angle if you do it by hand...
 
zero_zero

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........
This is absurdity at it's finest. The government protecting the interests of global corporations at the expense of small business once again.
.............

Yeah, money talks, BS walks, that's how life goes...o_O
 
JohnWilson

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Had an interesting discussion with someone with inside FDA information. The issue seems to derive from a worry about labs using CAD/CAM systems to create abutments or screw-retained restorations that exceed angle correction specifications for FDA-approved implants. In other words, they don't want a non-FDA compliant abutment or restoration causing the failure of an FDA-compliant implant. The suggestion was, in order, to be on the safe side of things, a lab would need to register with the FDA (cost appx. $3800, and rising every year); and institute a Quality Management System to track lot numbers, designs, failures, etc... It was suggested that the total cost to be FDA compliant would be somewhere in the $7500-$10,000 range for the average lab - potentially more.

Other insights include that using CAD/CAM (with the exception of Sirona) to design/mill ANY abutment head or full contour restoration for a Ti base is a violation of the ruling, although it appears to be perfectly okay to hand wax and either press or cast whatever you like - go figure. The other really odd thing was that dentists are allowed to ask for a lab to mill an abutment or a screw-retained restoration, but a lab cannot market the ability to do so unless they are FDA registered and in compliance. So, this is aimed squarely at labs - there is no consequence to doctor for using a non-FDA compliant product as long as they knowingly request it. I believe this was referred to as "going off-brand".

Lastly, abutments have been labeled as a medical device and will be subject to the medical device tax. It appears that the entity milling the abutment or the entity selling the pre-milled Ti blank will be liable for collecting the tax. So, labs that outsource to FDA compliant milling centers should be charged the tax but are not liable for collecting a tax from the dentist or patient. If you are FDA compliant and milling your own abutments then the Ti blank supplier would collect the tax.

I have also been alerted that Nobel and Straumann will be issuing statements on this ruling in the very near future..


This is some of what I have heard as well.

The most interesting part is if the base manufacturers have already passed FDA on their product and their DME is locked then what is the issue? The cad software needs to be complaint. Also any abutment manufactured by a 510k manufacture to proper specs can be negated with any crown that is put on top of it? Think about how many off axis loaded crowns have been fabricated on poorly placed fixtures.

If they are going to regulate screw retained tops then what about traditional cement retained crowns. If a cad base falls under the same scrutiny as any stock abutment and there is no regulation for a cemented restoration over the top of a stock abutment then how can they regulate a milled top for a screw retained crown?

There are so many gray areas on this and just because we register and pay it in my eyes does nothing for the patient. Isn't that why all of this was supposedly regulated? Oh yeah the money thing may have a bit more to do with things.
 
rkm rdt

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What about tapped lingual screw holes?
 
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RJS8669

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This is some of what I have heard as well.

The most interesting part is if the base manufacturers have already passed FDA on their product and their DME is locked then what is the issue? The cad software needs to be complaint. Also any abutment manufactured by a 510k manufacture to proper specs can be negated with any crown that is put on top of it? Think about how many off axis loaded crowns have been fabricated on poorly placed fixtures.

Its my understanding that CAD systems that are FDA compliant have angle correction parameters that are not allowed to be exceeded. There is no such parameter with a Ti insert. To manufacture a screw-retained restoration will mean fabricating an abutment and a crown at the same time, and having the hole placed though all layers. The angle correction parameter for the abutment will presume such for the attached restoration, which isn't necessarily correct, but its at least headed in the right direction from the FDA's viewpoint...

If they are going to regulate screw retained tops then what about traditional cement retained crowns. If a cad base falls under the same scrutiny as any stock abutment and there is no regulation for a cemented restoration over the top of a stock abutment then how can they regulate a milled top for a screw retained crown?

With you on this - it makes no sense to be able to do an absurd angle correction simply because it was done by hand rather than by machine.

There are so many gray areas on this and just because we register and pay it in my eyes does nothing for the patient. Isn't that why all of this was supposedly regulated? Oh yeah the money thing may have a bit more to do with things.

Yeah, the more you look at it, the more it appears this is the result of a lobbying effort by the big boys...
 
2thm8kr

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This is some of what I have heard as well.

The most interesting part is if the base manufacturers have already passed FDA on their product and their DME is locked then what is the issue? The cad software needs to be complaint. Also any abutment manufactured by a 510k manufacture to proper specs can be negated with any crown that is put on top of it? Think about how many off axis loaded crowns have been fabricated on poorly placed fixtures.

If they are going to regulate screw retained tops then what about traditional cement retained crowns. If a cad base falls under the same scrutiny as any stock abutment and there is no regulation for a cemented restoration over the top of a stock abutment then how can they regulate a milled top for a screw retained crown?

There are so many gray areas on this and just because we register and pay it in my eyes does nothing for the patient. Isn't that why all of this was supposedly regulated? Oh yeah the money thing may have a bit more to do with things.
Come on John, don't tell me you are just going to fall in line. What happened to the guy who was responsible for the fireworks while driving incident. Hopefully he hasn't flown the coup.
 
JohnWilson

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Come on John, don't tell me you are just going to fall in line. What happened to the guy who was responsible for the fireworks while driving incident. Hopefully he hasn't flown the coup.
I have to be carful with you , you don't forget Sh!t


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JMN

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Come on John, don't tell me you are just going to fall in line. What happened to the guy who was responsible for the fireworks while driving incident. Hopefully he hasn't flown the coup.
Ohhhhh, do tell!
 
Tom Moore

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The large majority of labs are not in any way shape or form abiding by the laws already in place so why would they worry about this?
 
Car 54

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The large majority of labs are not in any way shape or form abiding by the laws already in place so why would they worry about this?

Wasn't there at one time in the late 80s to early 90s, where we were supposed to pay royalties to someone in England (overseas somewhere if I'm remembering right) who said he developed the refractory veneer technique? I can't remember for sure, but it was kind of a joke, with labs not complying with that one.
 
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So, the years passend bye. Any Updates yet? Still a 510k or any other stuff needed to legally sell inhouse milled abutments?
 
rkm rdt

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you didn't get the memo?
 
alfredmorad@gmail.com

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So, the years passend bye. Any Updates yet? Still a 510k or any other stuff needed to legally sell inhouse milled abutments?
Seppvh
Please contact me when you can, we have an inexpensive solution for your FDA Clearance
AL 248-926-8810
 
CatamountRob

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Yeah, what was it about?
 
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