ROCK HILL, S.C., Nov. 6, 2019 /PRNewswire/ -- Today, 3D
Systems (NYSE:DDD) announced that its new biocompatible
denture material, NextDent® Denture 3D+, has received
510(k) clearance from the U.S. Food and Drug Administration (FDA).
The combination of this new dental 3D printing material, NextDent
5100 dental 3D printer, and industry-leading intra-oral scanning
and dental software solutions yields an end-to-end digital
dentistry solution. As a result, customers can expect more
precise, predictable results than through analog techniques -
enabling more efficient, cost-effective creation of dentures for
patients.
Producing a denture using NextDent Denture 3D+ for the base, and
NextDent C&B MFH for the teeth on the NextDent 5100 results in
a final denture that is 90% less expensive to produce in 75% less
time than dentures created using analog methods. The digital
solution improves the patient experience as well, providing a
properly fitting device with fewer required office visits.
"With 3D Systems' Digital Denture Workflow, dental laboratories
and clinics are now able to produce dental devices at dramatically
increased speed while reducing material waste and capital equipment
expenditure as well as reliance upon milling centers," said
Rik Jacobs, vice president, general
manager, dental, 3D Systems. "FDA clearance of NextDent Denture 3D+
is the last piece that creates a trusted end-to-end workflow –
giving prosthodontists a competitive advantage while improving the
patient experience."
NextDent Denture 3D+ material possesses excellent mechanical
properties (in accordance with ISO Denture Base Standards) and is
capable of producing dentures rivaling conventional denture base
materials. 3D Systems offers the largest available color palette
for a denture base material, which enables dental labs and clinics
to deliver a final product that most closely matches a patient's
gums for a natural looking aesthetic. This material joins the
company's portfolio of 30 unique NextDent resins – the largest
number available from any dental 3D printing material supplier.
NextDent 3D printing materials for medical devices are
biocompatible and CE certified (CE certification is pending for
NextDent Denture 3D+) in accordance with Medical Device Directive
93/42/EEC, listed at the FDA, and registered in various other
countries. The complete NextDent portfolio – for both medical and
non-medical devices – is suitable for a wide range of
applications.
Forward-Looking Statements
Certain 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
review any forward-looking statements made by management or on its
behalf, whether as a result of future developments, subsequent
events or circumstances or otherwise.
About 3D Systems
More than 30 years ago, 3D Systems
brought the innovation of 3D printing to the manufacturing
industry. Today, as the leading AM solutions company, it empowers
manufacturers to create products and business models never before
possible through transformed workflows. This is achieved with the
Company's best-of-breed digital manufacturing ecosystem - comprised
of plastic and metal 3D printers, print materials, on-demand
manufacturing services and a portfolio of end-to-end manufacturing
software. Each solution is powered by the expertise of the
company's application engineers who collaborate with customers to
transform manufacturing environments. 3D Systems' solutions address
a variety of advanced applications for prototyping through
production in markets such as aerospace, automotive, medical,
dental and consumer goods. More information on the company is
available at www.3dsystems.com.
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SOURCE 3D Systems