TheLabGuy
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I wanted to start a thread on this because the FDA and I suppose the NADL will be posting something official on this in the next week or so. We've all known that the Abutment interfaces obviously need 510K approved via the FDA. I know most of us here don't mill the interfaces but whats about to change is the enforcement of what your making above the interface...i.e. hybrid abutments. I didn't know that the FDA does require a 510K approval on what's above the interface as well. According to what I currently know (and feel free to chime in if you have additional information),that the FDA does a 'fatigue' test on the abutment, which means it does include whats above the interface per the 510K. Therefore, if you're making hybrid abutments in-house, you have to have 510K approval unless...you have a closed system (only two are 510K approved) Sirona, Biodent. Also, that UCLA abutments DO NOT fall under this 510K requirement because they are hand made. Although 3Shape already has the 'fatigue' restrictions/limitations built into the software, Exocad is working on it to what I know now, but this does not mean you are 510K approved. Like I hinted to earlier, this is relatively new information to me, if you know more, please share or if I shared something wrong, please correct me.