Subject: Discontinuation of all non-FDA-cleared libraries - Abutment Designer in 3Shape Dental System 2015
Dear Partner,
We would like to inform you that as from the
end of February 2015, all non-FDA-cleared abutment components/libraries in
3Shape Dental System™ 2015 will no longer be available.This willbecome effective with our next patch release of Dental System™ 2015 (15.2.0 version). This is due to a request from the FDA and applies only for installations
in the US.
In order to make sure that your libraries will
continue being available in Dental System™, we would urgently like to ask you to send us documentation in form of a
copy of your 510(k) clearanceletter that your respective libraries only consist of FDA-cleared components to the extent that clearance is required for said component.
Secondly, please
signattached confirmation letter stating that your library only consists of FDA-cleared components to the extent that clearance is required for said component.
Once we receive the above documentation from you, we will be able to include a check mark in your library in Dental System™ to make sure that your library will continue to be enabled in the system.
Please note that this does not require any changes to your existing libraries; as usual it is only important that your library is encrypted – which we assume is already the case. Please be aware that you are responsible for the fact that your library only contains FDA-cleared components to the extent that clearance is required for said component.
If you should have any questions, please contact Hanne Nielsen (
[email protected]).
Thank you very much for sending the documents to Ivan Meshkov (
[email protected]) as soon as possible.
Kind regards,
Larissa
Please note that we advise you to no longer use non-510(k) cleared components/libraries while awaiting the new software version 15.2.0.
And since this is due to the FDA, it will only pertain to US markets.
I doubt this will have any real effect on those scanning from models.
