FDA & milling abutments in house

[Tom Moore]

It takes money and organization to advocate and see results.

That is not the lab tech way.

\Lets do it the way we have always done it and look for a different result..........That's the ticket.

 

[ChrisBWJ]

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

There isn't a traditional "abutment post" as we would expect in an implant abutment, but the same mechanical factors and forces are in play. If the implant to occlusal force angle exceeds what the system was tested to, then it could cause failure of the implant, the Ti-insert, or Zirconia topper. Design parameters must still be enforced. The FDA still considers them an abutment and they fall under the 510k requirement. This is the information that I am hearing from the FDA and through performance standards development committees I am a part of. How it all plays out remains to be seen.

Oh and the current registration fee for the FDA is $3,845 for 2016, and estimated to be $3,872 for 2017. Thank you Obamacare!

This fee covers only registration, it does not include the cost of submitting a 510k, fatigue testing, development and implementation of an acceptable QMS, etc..

 

[JohnWilson]

There isn't a traditional "abutment post" as we would expect in an implant abutment, but the same mechanical factors and forces are in play. If the implant to occlusal force angle exceeds what the system was tested to, then it could cause failure of the implant, the Ti-insert, or Zirconia topper. Design parameters must still be enforced.

This is what I understand as well and some Cad Bases that have been FDA cleared have these parameters locked down to cover these tested and approved standards in a DME that can not be easily changed.

I think this is a GOOD thing, the problem as I see it is not the meaning behind why its being done but how its being done.

 

[Macron Dental Lab]

WHY instead of looking in a stupid implant top mill or hand wax the FDA don't focus on all the crap that get into the us dental market done in labs out of the country with no regulation no rules and doctors paying 20 dollar for a no questions ask crown. There put your nose there FDA DIG, DIG, AND DO MORE DIGGING ..

 

[2thm8kr]

There isn't a traditional "abutment post" as we would expect in an implant abutment, but the same mechanical factors and forces are in play. If the implant to occlusal force angle exceeds what the system was tested to, then it could cause failure of the implant, the Ti-insert, or Zirconia topper. Design parameters must still be enforced. The FDA still considers them an abutment and they fall under the 510k requirement. This is the information that I am hearing from the FDA and through performance standards development committees I am a part of. How it all plays out remains to be seen.

Oh and the current registration fee for the FDA is $3,845 for 2016, and estimated to be $3,872 for 2017. Thank you Obamacare!

This fee covers only registration, it does not include the cost of submitting a 510k, fatigue testing, development and implementation of an acceptable QMS, etc..

IF, the implants are placed properly angle correction shouldn't be a problem. Does this mean the FDA will start subjecting surgeons to fines for unguided placement? Where does it end?? * copied from my favorite thread.

 

[droberts]

Are there fines/sanctions in place? If not why don't you just mill until they do?

Its not like your speeding until you get caught. The end result is whats best for the patient.

JKraver...Santa Claus is watching you

 

[RJS8669]

There isn't a traditional "abutment post" as we would expect in an implant abutment, but the same mechanical factors and forces are in play. If the implant to occlusal force angle exceeds what the system was tested to, then it could cause failure of the implant, the Ti-insert, or Zirconia topper. Design parameters must still be enforced. The FDA still considers them an abutment and they fall under the 510k requirement. This is the information that I am hearing from the FDA and through performance standards development committees I am a part of. How it all plays out remains to be seen.

Oh and the current registration fee for the FDA is $3,845 for 2016, and estimated to be $3,872 for 2017. Thank you Obamacare!

This fee covers only registration, it does not include the cost of submitting a 510k, fatigue testing, development and implementation of an acceptable QMS, etc..

Sorry to belabor the point, but,,,

What if I simultaneously design an abutment to be milled by a registered implant manufacturer AND an FCZ with a screw channel to be milled in house, and then lute the two together? If the abutment is cleared by the manufacturers FDA requirements, am I in the clear on milling the FCZ? Or do both components of the final restoration have to be milled by an FDA cleared manufacturer?

Also, it seems to me that under these rules I could modify a stock abutment by hand and I would be ok? Which if true is pretty dumb...

 

[JKraver]

Its not like your speeding until you get caught. The end result is whats best for the patient.

JKraver...Santa Claus is watching you

Hmm that would be a serious consideration if I were milling illegally.

 

[RJS8669]

So, this morning I received this


-


Coincidence? What to do...

 

[JKraver]

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.

You know, it is one of those things. That my bosses always bitched about, that I just took as fact. I do not personally know even how much your annual fees are. Sorry for saying that, I shouldn't have.

 

[edwarddental]

on the mean time FDA approved all s***t that coming from China . Just pay the fee . No big deal

 

[ChrisBWJ]

What if I simultaneously design an abutment to be milled by a registered implant manufacturer AND an FCZ with a screw channel to be milled in house, and then lute the two together? If the abutment is cleared by the manufacturers FDA requirements, am I in the clear on milling the FCZ? Or do both components of the final restoration have to be milled by an FDA cleared manufacturer?

This would be fine since you are milling a crown which is exempt.

I suspect they are cracking down on the "CAD/CAM" abutments because of the ease and speed at which they can be designed and manufactured. Old school grinding or casting used to be the exception rather than the rule. Today it is so easy to design and mill a custom abutment. I'd love to know if there is a statistic that shows the ratio of the placement of stock vs custom abutments between 2000 and 2014.

 

[RJS8669]

This would be fine since you are milling a crown which is exempt.

I suspect they are cracking down on the "CAD/CAM" abutments because of the ease and speed at which they can be designed and manufactured. Old school grinding or casting used to be the exception rather than the rule. Today it is so easy to design and mill a custom abutment. I'd love to know if there is a statistic that shows the ratio of the placement of stock vs custom abutments between 2000 and 2014.

If that's so - this is a classic case of government overreach. Under this, I presume it would be okay to make a Peek or eMax abutment using a Ti insert as long as I pressed abutment material but didn't mill it? And UCLA custom cast abutments are still okay? This is mind-boggling.

 

[Affinity]

So why not hold the manufacturer accountable. If a machine or software is capable of meeting their requirements, why not leave the human factor out, which is nearly impossible to fix, (the reason they dont monitor the actual surgeon or their work) and just give us our tools that do the job right. I thought this is why every product we use is tested and then approved. Force us all to be certified if theyre concerned about our abilities! Micromanaging should not be the goal of the feds.

For Gods sake, was the hammer used to destroy the bruxzir crown FDA approved?!

 

[JMN]

This would be fine since you are milling a crown which is exempt.

I suspect they are cracking down on the "CAD/CAM" abutments because of the ease and speed at which they can be designed and manufactured. Old school grinding or casting used to be the exception rather than the rule. Today it is so easy to design and mill a custom abutment. I'd love to know if there is a statistic that shows the ratio of the placement of stock vs custom abutments between 2000 and 2014.

I can tell you flat out that my previous lab had exactly 1 case in about 20 years that the stock abutment did not need/get modified.

 

[ChrisBWJ]

I can tell you flat out that my previous lab had exactly 1 case in about 20 years that the stock abutment did not need/get modified.

I don't disagree. I think their rationale is that you can't really change the correction (post) angle all that much when modifying a stock abutment.

They don't seem to be paying much attention to UCLAs, for whatever reason.

 

[JMN]

I don't disagree. I think their rationale is that you can't really change the correction (post) angle all that much when modifying a stock abutment.

They don't seem to be paying much attention to UCLAs, for whatever reason.

UCLAs need a technician, cad/cam needs a script kiddie.

A technician can possibly produce a superior outcome in cad/cam over UCLA, but a script kiddie has no clue "why" and may never bother to learn unlike the technician who hungers to learn.

Really , I just think they (the rule making body) don't have a clue and aren't aware/don't remember UCLA abutments processes exist in the first place, it's a committee of fiefdom's heads, not a knowledge circle.

no flame wars intended to be started, but we've all seen someone bang out a design that is "acceptable" to the machine/software only.

 

[rkm rdt]

The big implant companies appear to be behind this. They sell uclas .They don't like it when you use 3rd party components and they don't like it when you mill your own abutments.
Why is Sirona the only one approved? Dentsply.
That would explain the email from Atlantis I received.

 

[Denturepropgh]

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.

I was just awarded a Pillar Scholarship from the FDLA for all-expenses paid CDT certification testing. Deadline for application for scholarship is August 15th. They have many different grants and scholarships. I'm very thankful to all those who have donated so that I have the opportunity to "test my might". I think you can apply every year. I wonder if I can get my MDT and not have to spend a dime....I'm going to test for Complete Dentures on March 10,11 2016. Gonna bang em all out in one weekend. I think the sites are great resources, however I do feel that some things are a bit overpriced, such as that PowerPoint presentation the NBC sells for the practical exam. I felt a bit sour after that purchase. It didnt tell me anything that the Air Force Manual did not thoroughly explain. Me = Sucker

 

[Denturepropgh]

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.

Ohhhh, burn!!