Nobel Procera 2G scanner

[Beatrice]

Benard, one problem with your bars being sold as "custom device", not "medical device". We here in the states
are not legally allowed to sell a device that has not been approved by the FDA. We operate as a medical device
facilities. So not that we cant buy from you, its that we cant legally re-sell it. Very fine g-r-e-y l-i-n-e.
If that was the case, there would be no FDA issues of labs doing business with China. These types of
laws are not fair to labs such as Primus, *** and others who mill under the approval of the FDA.

Hi Dr. Roberts, TRUE and double TRUE.

What you miss in the story is that by BEING a registered dental Laboratory at the FDA, all product that I sold in USA can be re-sell by any registered dental laboratory in USA regarding FDA. No need for more registration that just being an legally operated dental lab.
My only important point to be approved by FDA is that ALL product that I sell in USA that will end in human body (such my bars) need to be ordered by a "DOCTOR" under a prescription. That mean when a lab send me a case it need to come with a prescription. And so far it how we work since Biocad.

Nobel Biocare is doing the same since 2009 when they made the acquisition of my old company that we were doing the same since 2006 the day I started with my first USA dental lab.
FDA have made a lots of change during the last few years but nothing regarding this reality that I would say MANY MANY dental technician are lost in all this paper work and laws.
But be assure that if you buy a bar from me and re-sell it your are bullet proof with FDA.

Dr. Roberts if you want more info on this topic feel free to contact me, and just to let you remember the bars that you are using everyday, it's me and my brother that have done the whole technology INCLUDING the legal paper work to sell in USA.



PRIMUS/*** :
WHY in the world I would share my company secrets with a competitor? My machines, software and scanner are all have been developed in collaboration between some industrial manufacturer with my team of engineer. why I would show you which they are so you can start trying to copy me?

At the end what is important is the quality of my final product, and regarding software here a demo of my viewer made on the same kind of engine as my design software :


With all the respect to you ***, I can share a lots of thing but not that and if you cannot understand why that the main reason why!

Best regards to all,