FDA position on CAD-CAM milling of custom abutment . . .

[lcmlabforum]

Will this invalidate any Glidewell, Origin or other zirconia abutments?
http://us11.campaign-archive1.com/?u=ccc66625071a6de063f48922c&id=1cbd4b3370&e=06dabcc5cf
I don't know how to interpret this.
Even Etkon cannot make their own abutments?
And other third party like the Preat/Dynamic abutments now no longer legit?
How about DESS, etc?
LCM

 

[rkm rdt]

I think ISIS is probably excempt too.

 

[2thm8kr]

The majority of crazy angle corrections could be solved by surgeons.
Just because bone is there doesn't mean it is a successful placement.
This industry is being stifled and over regulated by the Government due something that is not entirely in our control.
What is the NADL and any other so-called advocacy group doing to combat over zealous regulation??

 

[CoolHandLuke]

i am pretty confident the FDA's 510k thing is >2 years out of date. very confident nobel, atlantis, straumann, etkon, dess, bio, and tons of others have 510k's published and valid.

it would strike me as incredulous that they do not. besides which this is "lab made" abutments, not standard abutments. so it would need to fall to labs to get a 510k, not implant manufacturers.

so in that list maybe only Atlantis needs to have a 510k but even then i doubt it, as they are an implant manufacturer as well.

companies like Axis, would need one. or Vulcan.

 

[2thm8kr]

I think ISIS is probably excempt too.

That's because the Socialists are worried about hurting their feelings.

 

[rkm rdt]

baby boomers

 

[CoolHandLuke]

boomers because they suicide bomb? lol

 

[Brett Hansen CDT]

Atlantis is 510(k) cleared.

 

[lcmlabforum]

I think ISIS is probably excempt too.

I think ISUS was bought by Dentsply, so it should automatically included.
I believe this was circulated by them in an email, and wonder if they are doing this to spite the competition
actually.
LCM