The goal of this is to learn from our experiences how to avoid these types of companies.
We recently met with a custom abutment milling center- a smaller local player in southern california and ran into numerous issues regarding the source of their materials, quality control processes and their willingness to reverse engineer every implant system they could get their hands on.
As a supplier of components we adhere to FDA guidelines and the manufacturing complies with ISO 13485-2003 quality management.
There were several questionable tactics that they implemented including-
1. using lab screws as final screws (using a temporary screw as a final one is completely unacceptable)
2. not providing MSDS on the titanium material they are milling custom abutments (do you know where the material is coming from?)
3. designing any degree of custom abutment (over 30 degrees) - bad design equals bad outcomes...
4. quality control - how do they test for tolerance and fit of the connection, what standards to they comply and adhere to.
5. reverse engineering of patented designs - we know this is happening but at what point does the implant manufacturer request information on all of the milling centers customers too?
We believe that as the market for custom abutments grows more competitive and these unscrupulous players emerge that these types of unethical practices will become more commonplace.
I would ask your milling partner for-
1. MSDS documents on the source of their materials
2. FDA documents demonstrating that they have a valid FDA for the material or product they are providing
3. The label for the screw including lot number.
4. How are they making their custom abutments- with a block of titanium or utilizing a block with the interfaces already milled.
If they cannot provide you this information then go somewhere else.
I have no issue disclosing this vendor to you however please contact me directly.