NADL - FDA discussion

[JohnWilson]

I hear they have released their assessment of the law, who has received their copy? Please post it

 

[Ryan]

Hi John,

here is a link.... http://nadl.org/sl_files/487CEA77-5056-A04E-37A0DDED9A8D218E.pdf

I would be really interested to hear your opinion on this, when you have a moment.
Ryan

 

[CoolHandLuke]

zr-ti good

ti abut bad

make ti abut by hand ok

clearly the computers are at fault. surely if you make it by hand it will be better.

 

[CoolHandLuke]

i want to see someone hand grind a ti blank by hand, water cooled and all.

 

[rkm rdt]

 

[CoolHandLuke]

 

[Sam-CAP]

View attachment 20151

I like to call it "The death wheel", perfect for all projects.

 

[Yourgoes]

"One odd result of this is that a lab can mill an abutment blank by hand but cannot use their best tools (CAD/CAM milling) to achieve what would be the same, or likely a better result for the patient.."

 

[rc75]

i want to see someone hand grind a ti blank by hand, water cooled and all.

This should work...

 

[Sam-CAP]

I'd like to see an actual "Official FDA Statement", is there such a thing? Notice at the bottom of the NADL article:

Nothing in this article is intended as, nor should it be construed as or relied upon as legal advice. Please consult your legal advisor or a qualifi ed compliance consulting professional to determine any applicability to your individual business activities.

 

[2thm8kr]

My fees for hand milled or UCLA type abutments for angle correction greater than what will be allowed in CAD programs are now quadrupled.
Had to get my wooden club and stone chisels out of mothball storage.

When the restoring doc complains about the fees, I will refer him to a surgeon that works with me planning implant cases. I suggest you do the same, time to run the cowboy surgeons out of town.

 

[Taylor]

I'd like to see an actual "Official FDA Statement", is there such a thing? Notice at the bottom of the NADL article:

Nothing in this article is intended as, nor should it be construed as or relied upon as legal advice. Please consult your legal advisor or a qualifi ed compliance consulting professional to determine any applicability to your individual business activities.

Hey sam, any news on what you guys at cap are doing? i spoke with some one and she said you guys were talking to your legal advisers.

 

[CoolHandLuke]

My fees for hand milled or UCLA type abutments for angle correction greater than what will be allowed in CAD programs are now quadrupled.

i got a warm fuzzy feeling when i read that sentence.

 

[2thm8kr]

i got a warm fuzzy feeling when i read that sentence.

It will take at least four times as long to do it the old way rather than with CAD. I didn't place the implant and can't move it. The lost revenue has to be made up somewhere.

 

[CoolHandLuke]

i like it because it is entirely justified due to legally binding verbiage. since it can no longer be done the cheap way, we have to do it the expensive way. puts a giant smile on my face.

 

[Sam-CAP]

Hey sam, any news on what you guys at cap are doing? i spoke with some one and she said you guys were talking to your legal advisers.

First I'm not 100% up on whats going on, my thoughts, feelings, and writing is my opinion and not CAPs. lol

For CAP its complicated, we are a manufacturer as well as a provider of equipment that manufactures. The first step is to figure out when this ruling will be or if it is official and how long we have to put the necessary compliance parts in place. To do this CAP is hiring compliance people (lawyers or FDA people, I'm not sure). The goal is for CAP to be within compliance (we might be already? Again, not sure) and of course for our customers milling abutments to be in compliance or have a very clear path on whats involved and most important give them the tools to speak intelligently to their customers about whats going on.

 

[Taylor]

First I'm not 100% up on whats going on, my thoughts, feelings, and writing is my opinion and not CAPs. lol

For CAP its complicated, we are a manufacturer as well as a provider of equipment that manufactures. The first step is to figure out when this ruling will be or if it is official and how long we have to put the necessary compliance parts in place. To do this CAP is hiring compliance people (lawyers or FDA people, I'm not sure). The goal is for CAP to be within compliance (we might be already? Again, not sure) and of course for our customers milling abutments to be in compliance or have a very clear path on whats involved and most important give them the tools to speak intelligently to their customers about whats going on.

Cool let me know becaus i am one of those customers and I would like to continue milling i-h abutments as well as follow the rules.

 

[shane williams]

So has this issue been resolved? I'm very confused now. I had an article dropped off "Are You Purchasing illegal Abutments" and it continues to state that you can only "hand-mill" blanks.
And what's to stop me from saying "yes it's a blank, yes I hand milled it" Who is going to know if it's hand-milled or CAM milled.

 

[CoolHandLuke]

i challenge you to say something along the lines of "I realized this hand milling was time eating and very laborious so to save time and generate an abutment with less rough edges and less wrist pain I programmed a special servo-controlled lathe with the exact shape i desired, but in doing so it has gone and cost me money to set it up so i'm still charging you 5x my old fee"

go on

 

[Tayebdental]

My fees for hand milled or UCLA type abutments for angle correction greater than what will be allowed in CAD programs are now quadrupled.
Had to get my wooden club and stone chisels out of mothball storage.

When the restoring doc complains about the fees, I will refer him to a surgeon that works with me planning implant cases. I suggest you do the same, time to run the cowboy surgeons out of town.

"time to run the cowboy surgeons out of town"
Are surgeons behind this or the lobbying of implant companies?.