Thanks for clarifying @JenniferMilne. This bit of info actually makes me less concerned, because it sounds like you guys will eventually find a solution and you just need time for more testing. Thanks for being transparent with us!
One thing that caught my eye in the Form3B announcement was the statement that the Form3B could print with all Formlabs materials. I’m assuming that includes the engineering materials as well.
It’s weird, my Formlabs Solutions Specialist told me, with confidence, the 3B would only support dental materials, which conflicts with what was stated in the announcement.
Just to clarify so there’s no confusion at all, the Form 3B has no limitations on what materials it can print with, including non-dental and engineering materials.
Apologies for the mixed signals! If you’d like to message me privately with the name of who you were talking to I’d be happy to make sure everyone is on the same page.
Does that mean that the Grey Pro material that is currently not available on the FORM 3 due to compatibility issues with the tank will print on the FORM3B? If so will the fix now be rolled out to the FORM3 or can i swap my FORM3 for a FORM3B?
It does not. Same tank, same limitations (for now).
@DKirch was trying to say 3B isn’t “castrated” as someone put it in one of the threads, but works with the same palette of resins as 3.
Yet more mixed signals and not clear language. The Form 3B is just a Form 3 with different firmware. The ability to print with Grey Pro and RIgid and Elastic has nothing to do with firmware, it is based on the tray. So no, Form 3B will not be able to print with Grey Pro, Rigid, or Elastic out of the gate until they solve the tank issue, which will also apply to the Form 3.
Yet another reason this whole Form 3B thing is some bullshit and an absolutely terrible marketing campaign. Why are you pretending it is a different machine when it is the same thing? Just make dental users pay more for the damn dental resin and a dental support plan. You already have the gate that requires a toll, no reason to put up another gate with another toll. Ridiculous.
Because if you print medical devices
you have to use certified medical printer
The European Union considers 3D-printed implants a custom-made medical device under the old 93/42/CE Directive (MDD 93/24/CE). However, the new Medical Device Regulation MDR (EU) 2017/745 states that 3D printed implants are not considered custom made medical devices under the CE mark. It also says that these devices should still follow all the directives according to their risk classification
I was under the impression that a medical device status was only linked to the resin and post exposure system as that’s what will ensure the resin is cured to the correct standard. Is that not the case?
The whole path needs to be certified.
Anything the resin comes into contact with, including the tank, platform, printer internals…
Certified by whom?
The FDA in the States and a bunch of other organizations depending on where in the world you’re located.
Even beyond tank, platform, printer, resin, wash, and cure, the user also need to certify the specific software and firmware as part of the process as well.
If even the firmware changes you basically need to start all over again and re-certify every chain in the process with the new software.
This is one of the main reason’s we’ve silo’d off the dental/biocompatibility printers into their own bucket, because the cadence and type of changes will need to be completely different from the rest of our printers.
You guys would be wise to just say that in your press release. “Due to stringent regulatory demands…blah blah”.
@DKirch Formlabs Community Manager,
Hi, Its great to see that you talk of certification by the FDA. As the Form3B is aimed at the Dental Market can you confirm if it CURRENTLY holds ANY certification relevant to producing medical devices in a certified and regulated environment?
If NOT, please would you advise when Formlabs is likely to gain certification for a process that includes the Form3B to produce FDA controlled additive manufactured devices approved for dental applications. What time scale is anticipated or estimated?