Atlantis has numerous FDA 510k's for their custom abutments for different systems-
http://www.510kdecisions.com/product_codes/index.cfm?fuseaction=companies&product_code=NHA What I have learned in going through an FDA process (for an implant) is that there are different tests required based on the type of implant and abutments you are providing.
If a stock angled abutment is part of the submission (versus submitting a straight abutment) then they go through additional static and dynamic stress testing which you may read that a company goes through 5 million cycles of stress testing to determine when they will break.
So given that a custom abutment is often angulated or not considered a "straight" abutment one would assume that a custom abutment would go through the same static and dynamic stress testing testing that a angled abutment would go through.
The issue with fit is another story since this requires extensive engineering, tolerance testing, fit testing, engineering drawings, various calculations to determine tolerance and fit to demonstrate that the part is cross compatible with an existing implant. That is part of the 510K submission for cross compatible abutments and would be the same for a custom abutment. So how they fit should be accurate enough if they are FDA approved.
Now other issues occur post production regarding the testing of the tolerance and fit of the custom abutment part and therein lies the mystery - what true testing goes on to ensure that the milled custom abutment has the correct tolerance and fit based on the original CAD drawings of the 510K submission for the connection? Companies do not do this because it requires metrology equipment (which costs a lot of money but not really) and time to do this testing to ensure accuracy and fit and accepted tolerances of the part. At DESS, since we make stock parts, we do this on every batch of parts with two different metrology systems, testing a sample of the parts to ensure they fall within a 10-20 micron accuracy of the original CAD drawings.
This way we know that if the parts don't fall into that range we start over making a new batch and destroy the others.
This is why the premilled interface titanium blocks are the future for this business because the manufacturer can test and validate the fit, tolerances, and cross compatibility prior to sending to their clients.
Health Canada and FDA are the two regulatory bodies who require the tolerance, fit, and cross compatibility testing as part of the submission. CE does not require this.
We have Health Canada and pending FDA.
In other words if you are working with a supplier of any abutment that does not have Health Canada and or FDA then you have a much higher chance of running into the fit issue, tolerance issues, increase of micro movements, and screw loosening or breakage issues.
This is what caused this entire crackdown to begin with. A few bad apples making aftermarket abutments that were creating failures of implants (heard from a consultant that wrote the specs on these regulations). Another topic for another day.