they are not a closed printer and will use the Nextdent resins.uh, how exactly do you plan on denturing with that thing they only have resin for ortho, guide, tray, model. none for denture base, none for teeth. i'm 99.8% sure if i check HC MDALL i won't see them listed.
So let me throw this into the Mix.... What If I used the B9Creations 530 printer vs. the CARA printer??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
Territory Sales Manager
Whip Mix Corporation
Dental Technology Solutions
800-626-5651 ext. 1425
The only difference is what was validated by the resin manufacturer listed on their quality system and the instructions for use. Like all regulated products its very specific on the equipment and process used to make the final product. Even though you are technically correct if they list the Kulzer printer and not the B9 in the IFU and documentation its an incorrect usage and in turn breaking its biocompatiblily in the eyes of regulators. It would be the same if in the IFU they list their Hi-light UV cure unit (I think thats what its called) and not general light frequency and timing, if you don't use their UV cure light indicated you are breaking protocol thus losing its approval for human use.So let me throw this into the Mix.... What If I used the B9Creations 530 printer vs. the CARA printer??
If this post seems like it makes no sense, google the two printers. $5000 or so difference.