@Dxxxx
Ya, it’s all pretty vague, even FDA’s own requirements. Getting back to the main point though, the biocompatibility of ISO 10993 just comes down to tissue contact for >30 days. I remember reading about Form’s specific test somewhere, but I think they just printed a few parts and left them on mucosal membranes in mice for > 30 days - or something like that. That part’s fine, I can only assume they followed proper ISO protocol for that. In the IFU that comes with the biomedical resin, the instructions only state that a UV based SLA printer be used - not the Form 3B or the Form 2 specifically. They also only recommend a particular wash/cure cycle. I think the way the claims with cytotoxicity work in general are “We tested this under these conditions and got these results, use this information at your own discretion.”
In my opinion, the UV output of the cure station for an hour blows any variances of power output of the printer laser right out the water. While I can’t confirm that, the parts that come straight off the printer of both my elegoo and my form 3B look identical and have a blueish tint to them (when using biomedical resin). When coming out of the cure station, they both have an equal yellowish tint.
Everything you are saying about the variances in hardware requirements in the 3 and 3B printers makes complete sense. I dug deep down this rabbit hole and cannot find a single lick of difference. Even the short guide posted by Corey M above just says “the differences are that they are different.” I would think, somewhere in all of this, if there was a single claim Form could point to regarding differences, they would point it out. Even if it was just “The 3B has added software to comply with HIPAA regulations for Dental use.” That is a valid reason. Also, just checked, yup: Form 3B | Formlabs
When the Form 3B was released, you were required to purchase a $1500 service plan. I think Form realized they overplayed their hand and were crippling purchases by doing this, so they made up other reasons that their product is different. Even when the Form 3 was announced (before the 3B) it could print in biocompatible. Then they released the 3B and any Form 3 that shipped after that would not be compatible with Biomedical resins. Even on the announcement, Form said initial Form 3 purchasers would be grandfathered into having biomedical compatibility though EOL of their printer. Form 3B Announcement! - #8 by sunshine I don’t think it has anything to do with hardware limitations.
Again, I would love to hear from Form if they can back up their claims.