Carbon’s new 3D printable DENTCA resins have been released
approval from the FDA. As materials for
dentistry, DENTCA Denture Base II and DENTCA Denture Teeth
resins, are subject to an exception in FDA certification that
typically would not pass certification on 3D printer materials.
In this interview with Steven Pollack, Senior Staff
Research Scientist at Carbon, 3D Printing Industry learns more
anticipated role in the medical and dental market, and
plans for the future.
Digital traceability and rapid production
DENTCA Denture Base II and DENTCA Denture Teeth 3D printable
resins are the product of Carbon’s partnership with CAD/CAM
denture manufacturing specialist DENTCA. They allow technicians
without any traditional denture making experience, to make
prosthetics suitable for oral use.
In this same period, Carbon has also partnered with DREVE,
another dental specialist, that is collaborating to make 3D
printed gingiva gum masks and trays.
One of the advantages of 3D printing these devices, is that
Carbon offers digital traceability of the process, with part
serialization. Digital Light Processing (DLP) powered CLIP 3D
printing, also reduces the amount of time taken to complete a
Dental materials cleared by the FDA fall into one of two
classes: Class I which signifies minimum to no risk, and Class
II that indicates some risk. Class III would be high risk, but
very few dental devices make this grade, they also require
pre-market approval before they can be sold.
DENTCA Denture Base II and DENTCA Denture Teeth have Class II
approval from the FDA.
“Since the manufacturer of the final devices derived from these
materials are dentists, dental laboratories, orthodontists and
the like,” explains Pollack, “[the]FDA made the decision early
in its history to regulate the materials “capable” of
producing final dental devices.”
Materials in this class include alloys, ceramic and polymers,
all those “that take final form in the hands of a practitioner
The equivalence principle
For lower risk Class II, manufacturers can go through the
510(k) process. A process shared by
some spinal implants. By testing the 3D printable material
alongside another, already-martketed and safe medical device,
low-risk materials can achieve FDA certification.
Pollack explains, “The majority of Class II devices require the
manufacturer to provide pre-clinical (bench testing), and
sometimes limited clinical data to prove the device is
“substantially equivalent” to an existing product in commerce
that is FDA-cleared,”
“There are also some “Unclassified” dental devices,” he adds,
“That is, they were not put into a risk category in 1976, when
the risk- based system was set up. These are generally treated
as 510(k) devices because their risk has not been established.”
Who will come out on top?
The market for 3D printing in dental is getting increasingly
At the beginning of 2017,
3D Systems acquired NextDent as part of a deal
with Vertex-Global Holding B.V. revealing the intention to
use the company’s already approved materials in the Figure 4
configuration. This week VJ, 3D Systems CEO, announced the
launch of the NextDent 5100 3D printer, the first
products of this partnership. In an interview with 3D Printing
Industry VJ underlined the significance of this vertical
saying, “dentistry is the critical market for 3D Systems.”
Stratasys is also advancing in the dental market with
the Objet260 Dental 3D Printer, EnvisionTEC have served
the dental sector for a long time while DWS are one of the more
recent market entrants.
Meanwhile, Carbon has every intention of staying in the race.
“While I can’t get into specifics, we’ve seen firsthand the
many benefits that 3D manufacturing offers in this important
industry, and we’re committed to continuing to develop new
materials that enable us to improve lives.”
Could Carbon’s dental resins be material of the year? Make
your nominations for the
2018 3D Printing Awards now before they close next
Protolabs is sponsoring the 2018 3D Printing Industry Awards
design competition. Want to design this year’s
trophy? Submit your design now to win a 3D printer.
Featured image shows a 3D printed dental impression.
Photo via Carbon