3D Dental Printer vs. 3D Printers

JayH

JayH

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#21
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 dental models or model printers.

I find your original statement: "...you will need to ensure the hardware you use to print MODELS (if you print models) has class 2 certification for medical devices..." difficult to believe.
 
CoolHandLuke

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#22
Models are Anatomical representations yes?

so if Anatomic representations are governed by the FDA's 510k certificaptions, it goes to reason anything that prints a Model must have that certification.

Prosthetics are not patient anatomy, they are the negative (mirror) of patient anatomy, mating surfaces. so prosthetics would not be so governed unless by Material classifications.
 
JayH

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#23
That makes sense, but I've yet to see any specific regulatory language, on a regulatory body's web site, that convinces me.
 
JayH

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#25
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, subparts A-G.
 
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jamesg

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#26
Hi does anyone know if you could print, Implant models with removable analog with Formslab 2 I have not seen any, but Zahn Dental rep says you could.
 
JayH

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#29
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.
 
CoolHandLuke

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#30
Hi does anyone know if you could print, Implant models with removable analog with Formslab 2 I have not seen any, but Zahn Dental rep says you could.
whatever you design, you can print. so it falls to you to design a DIM and purchase the correct Analogs, after that you can print as many times in any material you want.
 
Wainwright

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#31
Hi does anyone know if you could print, Implant models with removable analog with Formslab 2 I have not seen any, but Zahn Dental rep says you could.
We have many Formlabs customers printing implant models but there are some complexities, not exclusive to Formlabs, depending on digital analog system is being used. What implant parts/system will you be using?

If you have a model file I'd be happy to print a model for you to test the fit and function for yourself.

One of my major goals over the next few months is to get an application guide put together for digital implant models that has recommended systems, workflow, and printer setup. One step at a time : )
 
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Lindsay Patterson

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#32
I am a huge believer in "you get what you pay for", but there are always exceptions to this rule. For example, I used to use the 100 dollar bottle of "dental" CAD spray until someone told me about the dollar bottle of foot spray you can use and does the exact same thing. As we all know the dental lab supply companies jack up their prices simply because its "dental". So when my boss came back from a 3D printing course with a 19,000 dollar tag on it, it made me look into this a little harder bc I am finding better printers for 1-2,000. Sounds like its a very reasonable idea as long as we buy software that has a class 2 certification for medical devises?
 
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Lindsay Patterson

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#33
JayH...Have you tried or know someone who has tried to use a non dental printer? Are you agreeing with me that it seems kind of silly to buy a dental printer vs a regular desktop printer? Do you or anyone else have 3d dental software advice?
 
capickettcdt

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#34
consulted with our 3D REP's. This is the current information that we have. Sherrie says you are free to contact her.

With 3D printing dentures this is how it works:

You cannot buy an open materials printer and just plug in a “510k” denture base resin and FDA compliant. In order to be FDA compliant you must follow a complete system. A complete system consists of the following: Printer + Resin + High Intensity Light curing unit. If you choose to go “outside of the box” you will NOT be FDA compliant.



Right now we are in the process of qualifying the Asiga Max and Pro2 printers with the Dentca resin which has it’s 510k. We have to go through a process to show that our printers will accurately and print their resin under certain guidelines using a specific high intensity light curing unit to bond the teeth. This will be complete by the end of February.



So a few examples:



If you have a Cara printer, you must use the Dima (Dentca private labeled) denture base resin and their high intensity curing unit to bond the teeth into the base in order to be FDA compliant. If you go outside of that approved system you can be fined by the FDA.



If you have a Carbon printer, you must use the Carbon (Dentca private labeled) denture base resin and their high intensity curing unit. Again if you go outside of that approved system you can be fined by the FDA.



Please note that as of right now… the NextDent resin does not have a 510k. Their resin is only classified as biocompatible Class IIa which only counts in Europe… not the States. So all of these people buying up NextDent printers to 3D print dentures are going to be disappointed.



Clear as mud?



PS…. Feel free to copy and paste my response as I am not on this message board. You can give my cell or email address to anyone that wants to reach out to me to discuss this topic







Sherri Weatherby

Territory Sales Manager

Whip Mix Corporation

Dental Technology Solutions

800-626-5651 ext. 1425

502-235-3182 cell
[email protected]

whipmix.com
 
capickettcdt

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#35
Update: Just FYI
  1. The curing unit with high light intensity is important to be part of the system in order to cure the material to reach the physical properties and biocompatibility that are stated by standards of dentures as a medical device class II
  2. NextDent and Envision Tec have 510(K) for their denture resin. kindly see the link: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162572.pdf
  3. The same manufacturer called Vertex –Dental for Next dent and Envision tec resin. And they qualified 3D system, Envisiontec , Rapidshape and Miicraft printers
 
cadfan

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#36
@ capickettcdt how about drill guides or trays its class 1 are they bound to a printer too ??
 
CoolHandLuke

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#37
class 1 materials are not, i think. with Health Canada if the material is Class 1 biocompatible, it doesnt even need to be listed under HC's license library.
 
JayH

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#38
JayH...Have you tried or know someone who has tried to use a non dental printer? Are you agreeing with me that it seems kind of silly to buy a dental printer vs a regular desktop printer? Do you or anyone else have 3d dental software advice?
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 space are pretty evident: 3Shape, Sirona, exoCAD, dentalWings (in no particular order, and certainly no bias as they all have their pros and cons)
 
C

Chus81

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#39
I work with Monnray and the results are acceptable in Geler models, splints, etc.
 
R

Rajashree2347

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#40
Why cant we use a regular 3D printer? There are really nice desktop printers for 1,000 vs. 18-19,000 ones for dental labs?
Dental 3D printers need to be very accurate, so the most common technologies used are SLA and DLP. Depending on the application, different resins are used, and many specialized resins have been created solely for dental 3D printers.
 
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