3D Systems receives FDA Clearance for NextDent Base

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3D Systems receives FDA Clearance for NextDent Base
NextDent Base 3D print resin gets US 510(k) clearance/Source: 3D Systems

3D Systems, the leading 3D printing solutions company in the world, revealed that it has received FDA clearance for NextDent Base resin material. The Food and Drug Administration granted a 510(k) clearance and Health Canada also approved this material, and it also has CE marking 1639.

NextDent Base material is intended for the fabrication of denture bases to support artificial teeth to form full or partial removable dentures. This is the company’s third generation denture base material for 3D printing, has excellent mechanical properties such as high break resistance and accurate and repeatable printability.

FDA Clearance for NextDent Base

NextDent Base is truly comparable to conventional denture materials in terms of durability and impact resistance, and it provides patients with long-lasting, impact-resistant dentures. Furthermore, for improved aesthetics, the material is available in four colors to match the most popular gingiva shades. Including NextDent Base in 3D Systems‘ digital dental workflow helps to drive new levels of speed, productivity, efficiency, and precision while also providing opportunities to improve the patient experience.

NextDent Base has already received positive market feedback. Nexus Dental Laboratory (Harrogate, United Kingdom)’s Steven Campbell, RDT FCGDent, has been conducting trial tests with the material.

“This new material is truly amazing! No support bar across the heels, lovely delicate supports which are easy to remove, and the fit of the teeth to denture and denture to bar show just how stable this is. We have just started trials with it, but already I can see the strength of this is going to make it an incredible material to keep an eye on. We are so confident in the strength we see on early prints that we are going to run some test partials with it.”

– Steven Campbell, RDT FCGDent, with Nexus Dental Laboratory

Additionally, Dr. Kunal Lal, DDS, MS, Board Certified Prosthodontist, at LAL Dental (New York, New York) said, “I really enjoyed testing the NextDent Base material. It is pink, flexible in thinner sections, and can be used for same-day interim RPD fabrication. Some of the other properties worth noting are minimal mixing, cleaning of residual material on the surface is easier, and improved strength.”

Although 3D printing for prosthodontics is becoming more popular, there is still a lot of room for growth. According to 360 Research Reports, the global 3D Printed Dentures market is expected to be worth more than $1 billion in 2021 and more than $2 billion by 2028. The use of digital workflows, such as 3D Systems’ digital dentistry solution, which includes its NextDent Base material and NextDent 3D printing technology, as well as a trusted connection with industry-leading software packages, results in a complete workflow that includes post-processing to ensure the best possible product.

Dental laboratories and clinics can now produce dental devices at dramatically increased speeds, while reducing material waste, capital equipment expenditure, and reliance on milling centers, thanks to 3D Systems’ NextDent solution. The patient benefits as well by reducing the time it takes to produce prosthodontics as well as the number of required office visits.

“Our goal is to ensure we are addressing our customers’ needs with our solutions, and this is yet another step in achieving that goal.”

– Chuck Stapleton, vice president and general manager, dental, 3D Systems

Stapleton added, “With the clearance of NextDent Base, we continue to add to our portfolio of dental 3D printing materials that are enabling dental laboratories and clinics to address a wide range of applications. These offerings are helping our customers accelerate the adoption of additive manufacturing as part of their workflows and drive new levels of speed, productivity, efficiency, and precision while also providing opportunities to improve the patient experience.” 

NextDent Base is the latest addition to 3D Systems’ portfolio of 30 distinct NextDent resins, the most of any dental 3D printing material supplier. The material is available in four colors to match a variety of aesthetics and can be ordered immediately.

NextDent 3D printing materials for medical devices are biocompatible and CE-certified in accordance with Medical Device Directive 93/42/EEC, are listed on the FDA’s website, and are registered in a number of other countries. The entire NextDent portfolio, which includes both medical and non-medical devices, is appropriate for a wide range of 3D-printed dental applications.

NextDent® is the registered trademark of NextDent.

About Manufactur3D Magazine: Manufactur3D is an online magazine on 3D Printing. Visit our Tech News page for more updates on Global 3D Printing News. To stay up-to-date about the latest happenings in the 3D printing world, like us on Facebook or follow us on LinkedIn and Twitter.

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Abhimanyu Chavan is the founder of Manufactur3D Magazine. He writes on Additive Manufacturing technology, interviews industry leaders, shares industry insights, and expresses his thoughts on the latest developments in the industry. You can follow him on LinkedIn, Twitter and Instagram.
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