Cares - FDA rules

CARES - FDA rules

Last doc Update on November 24th, 2021.

Purpose: describe the current implementation of the FDA rules applied in CARES Visual.

What is FDA compliance?

The FDA compliance is ruled by license and the same rule can technically be applied for DWOS and CARES (as it is exactly the same software). See below :

For all CARES customers in the USA, we do activate the ENFORCE FDA rules license key.

It means that to be inside the Straumann validated and FDA cleared workflow, you MUST use a FDA implant kit with a In-House Straumann material.
As of today we only have the Straumann implant kits with a valid FDA registration.

How to know if the implant kit has FDA registration?

An implant kit has a property called FDA registration, it needs to be filled with the implant FDA registration number/key.
See below an example.

In Order creation, the FDA implant kits have a 510k icon

There are 6 implementations:

1) FDA is activated by license, all customers in USA have the flag activated since Nov 24th, 2021

2) When it comes to Straumann Centralized Milling, USA customers are allowed to use the complete US Staumann supported Implant Portfolio (Straumann, Neodent, Medentika)

3) When it comes using the Straumann M, D, C-Series Milling, only the Straumann in-house material and Straumann implant kits with the FDA number/key are a validated workflow

4) When it comes to in-house (lab) milling with generic (3rd party milling machine) milling machine, there is no Straumann validated and FDA cleared worlkflow.

5) When it comes to generic order (generic material and generic implant kit) there is no filtering, which mean a users can create a generic order case to create an implant borne using generic implant (without fda key/number) + generic material and mill then in-house using a 3rd party milling machine.

6) Outside of the Straumann validated and FDA cleared workflow, the US customer is informed of the terms and risk. He can accept the regulatory notice.

Summary of Straumann validated and FDA cleared workflow

	Straumann Centralized Milling	Straumann In-House Milling	In-House Milling (in the laboratory)
Straumann FDA Implant Kit	YES	YES	YES with Disclaimer
Strauman non-FDA Implant Kit	YES	YES with Disclaimer	YES with Disclaimer
Third-party Implant kit (non-FDA)	NO	YES with Disclaimer	YES with Disclaimer