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I'd be interested if you find one...

900 builds easy. with cleaning if done carefully, even after the film gets hazy. I've been surprised by the durability of the membrane. And the 5100 should be noticeably faster than than the max, no?

I think you're mixing apples and oranges here. Hydrostatic or isostatic are the only two methods I'm familiar with. Homogenous Sequential Deposit looks like its still in the R&D phase - can't find much documentation on the process used. HIP is pre-sintered, so the machining happens after the...

No, the 5100 needs to be connected to the internet. How would you connect it to a computer?

You don't have latex gloves on when you're working the touch screen, do you? I've also found that a little bit more pressure than say a smart-phone requires is generally needed. Only failed prints I've had are due to not enough resin in the tray.

The material may be, but what about the process? And the process dictates the hardware. The 510k submission will specify what hardware was used to demonstrate substantial equivalence to an already approved marketable device. How does the FDA know that your Formlabs printer will cure the resin...

510k, 510k, 510k... <sigh>

Who needs a CAD design? Sounds like the process will mirror doctor-made temporaries

Sounds like a glitch in your design software to me.

Nobody ever likes to make offers.

Given IOS and services such as Full Contour you can bet it's coming...

I have not, but I do know people who have. If you're only printing models, then I MIGHT agree with you, depending on a whole lot of other considerations like cost, cost of ownership, cost of available materials, technical support available, blah, blah, blah The leaders in the dental software...

Go figure. I've read the FDA guidance paper and I'm not in the least worried about getting caught with my pants down, when it comes to printing dental models.

I've tried a number of different orientations, including flat. There's some interesting physics going on with that material.

I understand. Here's a quote from a 3D Systems representative concerning the use of the Gingiva Mask material from Nextdent: "When teams optimized gingiva mask printing, they made minimal supports and recommended to be placed on the lingual of the part. This is to ensure that the highest...

I'm too much of a cynic to let vendors tell me what I need to do to satisfy the requirements of the law. But even if I weren't, that article speaks to medical devices and again, there is no mention of models or model printers in the list of medical devices published under CFR 21, Part 872...

That makes sense, but I've yet to see any specific regulatory language, on a regulatory body's web site, that convinces me.

No, I'm trying to use the material for a different application, one that is not supported by Nextdent. I'm not sure that your part, given it's size, is supported either but was encouraged when I saw it.

Nothing at all on that page either with specific regulatory language that might indicate that model printers need a certain certification. I even read through the entire list of medical devices classified by the FDA under CFR 21, Part 872, subparts A-G (two more clicks) and found no mention of...

hmmm, Didn't work for me... Won't let me post a video, but the thing ends up flopping around like a fish out of water.