3D Systems Receives FDA Clearance for First-to-Market Multi-material, Monolithic Jetted Denture Solution
17 September 2024 - 10:30PM
Today, 3D Systems (NYSE:DDD) announced the Food and Drug
Administration (FDA) has provided 510(k) clearance for its
multi-material, monolithic (one-piece) jetted denture solution.
This first-to-market offering comprising two uniquely developed
materials — NextDent® Jet Denture Teeth and NextDent® Jet Denture
Base — as well as 3D Systems’ jetting technology, software and
services, enables the production of durable, long-wear,
aesthetically beautiful dentures. As a result of implementing the
Company’s FDA-cleared jetted denture solution, dental laboratories
can more efficiently deliver dentures, resulting in an enhanced
patient experience.
Glidewell, one of the world’s largest producers of restorative
dental devices, through its partnership with 3D Systems, received a
preview of this solution and is now in the process of implementing
it into its production workflow. “We take great pride in pioneering
the use of new technologies to continually enhance our products and
services,” said Stephenie Goddard, CEO, Glidewell. “We’ve worked
with 3D Systems for many years, and using their digital dentistry
solutions has helped us achieve tremendous success for our
patients. As the first dental lab to have access to 3D Systems’ new
multi-material, monolithic jetted denture workflow, we are looking
forward to implementing a significantly better denture solution for
our customers and their patients.”
“With the FDA clearance of our jetted denture solution, 3D
Systems continues to expand our market-leading digital dentistry
solution portfolio,” said Neil McCaffrey, vice president &
general manager, dental, 3D Systems. “Replacement of teeth is a key
pillar of our dental strategy, which is directly supported by this
latest innovation. Our jetted denture solution reflects our
commitment to the dental laboratory by offering a complete system
that enhances automation and profitability within a traditionally
labor-intensive workflow. This solution integrates innovations in
hardware, software, materials, and process expertise, delivering in
a single print session a one-piece denture with hard,
wear-resistant, aesthetically beautiful teeth, in combination with
tough, durable gingiva properties. Unlike other systems, our
printer can produce a denture with true multi-material
properties—not just color. With the growing use of digital imaging
and personalized treatment planning in dental clinics worldwide,
digitizing denture fabrication sets a new standard for creating
robust, precise dental prosthetics that patients can truly see and
feel. It's a win-win-win for laboratories, dentists, and
patients.”
3D printing continues to play a significant role in the
production of prosthodontics and its use is accelerating, driven by
the benefits it delivers for both manufacturers and patients.
According to 360 Market Updates, the global 3D Printed Dentures
market size was estimated to be more than $1 billion in 2021 and is
forecast to reach more than $2 billion by 20281. 3D Systems’
digital dentistry solutions, including its multi-material,
monolithic jetted denture solution, enable dental labs and clinics
to streamline dental device production, while reducing material
waste and lowering capital investment requirements. Patients also
benefit from faster turnaround times for prosthetics, fewer dental
appointments, and enhanced device durability and comfort.
For more information on 3D Systems’ jetted denture solution,
please visit the Company’s website.
Forward-Looking StatementsCertain statements
made in this release that are not statements of historical or
current facts are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause the actual results,
performance or achievements of the company to be materially
different from historical results or from any future results or
projections expressed or implied by such forward-looking
statements. In many cases, forward-looking statements can be
identified by terms such as "believes," "belief," "expects," "may,"
"will," "estimates," "intends," "anticipates" or "plans" or the
negative of these terms or other comparable terminology.
Forward-looking statements are based upon management’s beliefs,
assumptions, and current expectations and may include comments as
to the company’s beliefs and expectations as to future events and
trends affecting its business and are necessarily subject to
uncertainties, many of which are outside the control of the
company. The factors described under the headings "Forward-Looking
Statements" and "Risk Factors" in the company’s periodic filings
with the Securities and Exchange Commission, as well as other
factors, could cause actual results to differ materially from those
reflected or predicted in forward-looking statements. Although
management believes that the expectations reflected in the
forward-looking statements are reasonable, forward-looking
statements are not, and should not be relied upon as a guarantee of
future performance or results, nor will they necessarily prove to
be accurate indications of the times at which such performance or
results will be achieved. The forward-looking statements included
are made only as of the date of the statement. 3D Systems
undertakes no obligation to update or revise any forward-looking
statements made by management or on its behalf, whether as a result
of future developments, subsequent events or circumstances or
otherwise, except as required by law.
About 3D Systems More than 35 years ago, 3D
Systems brought the innovation of 3D printing to the manufacturing
industry. Today, as the leading additive manufacturing solutions
partner, we bring innovation, performance, and reliability to every
interaction — empowering our customers to create products and
business models never before possible. Thanks to our unique
offering of hardware, software, materials, and services, each
application-specific solution is powered by the expertise of our
application engineers who collaborate with customers to transform
how they deliver their products and services. 3D Systems’ solutions
address a variety of advanced applications in healthcare and
industrial markets such as medical and dental, aerospace &
defense, automotive, and durable goods. More information on the
company is available at https://www.3dsystems.com.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/fdc3f56e-aae2-4ae0-8908-21d185db789e
Investor Contact: |
investor.relations@3dsystems.com |
Media Contact: |
press@3dsystems.com |
1 360 Market Updates, “Global 3D Printed Dentures Market
Research Report 2022 (Status and Outlook)”, June 2022.
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