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Eric DeBuysser
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@CoolHandLuke so we just upgraded from 3 shape Dental System 2014. We are now currently running 2016 and cannot select local milling for Straumann implants. According to Straumann this is a "new FDA regulation that limits labs from milling OEM implants" and "you must fill out a 510k form for all products and get it approved by 3shape.
We heard some hardships with 2016, but is there any way around this? Straumann says they cannot provide an open library due to regulations. We've thought about attempting to go back to 2014 but there is no guarantee that the library or it's manufacturing processes will remain. Your thoughts?
We heard some hardships with 2016, but is there any way around this? Straumann says they cannot provide an open library due to regulations. We've thought about attempting to go back to 2014 but there is no guarantee that the library or it's manufacturing processes will remain. Your thoughts?
