Zzyzx
21
Just to add here: there is no FDA approved photopolymer based fixed restoration material. Removable is here to some extent, nightguards, RPDs etc. NextDent in Europe has limited clearance for crown material ( not that it’s beautiful- sorry Rik). But model and pattern materials do not fall under medical device regulation as they are not a part of the final device.
When you say my ‘own resin’, is this something you formulated with various acrylic monomers?
Zzyzx
23
Yes. That’s correct to a degree. There is more to it than that however. A bit the same as saying ‘yes’ to “you make spaghetti sauce with tomatoes?”. 
To be plain, I not only print a lot. But so much so that I started a company a few years back making additive materials for open systems.
Does anyone have a reference for proving that you don’t need to use FDA approved materials for working models. Thanks.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=872
If it is not in this list it is either not needed or hasn’t been approved. As long as you can prove there was no material contact with the patient with non approved materials you are just fine. But I recommend speaking with the FDA directly with your questions.
Chris Henry. How do I reach you? I’m heavily investigating 3D printing options for our lab, but I’m hitting a wall.
