RAPID

DENTCA Receives FDA Approval for World’s First Material for 3D Printed Denture Bases

Eplus 3D

Share this Article

d1It appears as though 3D printing is finally being taken seriously from a medical perspective. Over the last two months we have seen a flurry of activity when it comes to 3D printed medical products receiving FDA approval in the United States. Just last week the pharmaceutical company Aprecia earned FDA approval for their 3D printed ZipDose tablets of their seizure medication SPRITAM levetiracetem, and in the weeks prior to that, two other companies, joimax® and Oxford Performance Materials, earned approval for 3D printed medical implants.

With all the hoopla surrounding the Aprecia news, another major FDA accomplishment was achieved by a small denture company called DENTCA, which has gone relatively under the radar. The Los Angeles-based company officially earned 510(k) approval for the use of their new 3D printable material as a denture base.

d2

“After several years in development DENTCA’s new 3D printable denture base is finally cleared for use. We are very excited to begin applying this technology to continue revolutionizing the denture world,” explained Dr. Jason Lee, a creator of the DENTCA technology. “The material is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates; which will eventually replace traditional heat-cured and auto polymerizing conventional denture making methods. By improving the manufacture process with the help of precise 3D printers, we will be making the denture production process quicker, more accurate and more predictable.”

The material used within an SLA 3D printing process to create the denture bases has passed all the required tests for cytotoxicity, irritation, genotoxicity, sensitization, acute toxicity and material characterization for biocompatibility in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1.d3

“This clearance completely revolutionizes the denture manufacture process, which has barely changed in over 100 years,” explained DENTCA’s CEO Mr. Sun Kwon. “The new developments will create incredible possibilities for patients, as doctors will soon be able to 3D print final dentures at their office, allowing the manufacture process to be done in one day everywhere in the world. Stay tuned for new and exciting updates.”

The technology behind DENTCA’s products allows for the fabrication of full denture cases 2.5 times faster than traditional production methods. DENTCA’s precision and accuracy with their CAD/CAM technology, combined with 3D printing, is able to eliminate human error while also drastically cutting down on the number of visits and amount of chair-time that each patient has to invest prior to receiving their dentures. Additionally, the fabrication turnaround time was reduced from 30 days to just 5.

This is major achievement for the company, and one which could certainly play a significant role within the denture industry. Let us know your thoughts on DENTCA’s recent accomplishments in the DENTCA 3D printable Denture Base forum thread on 3DPB.com.

 

Share this Article


Recent News

3D Printing News Unpeeled: Silicone Support and Concrete in New Zealand and Saudi

“World’s Largest On-site 3D Printed Building” Completed in Saudi Arabia



Categories

3D Design

3D Printed Art

3D Printed Food

3D Printed Guns


You May Also Like

ICON Tackles Affordable Housing at SXSW 2023 with 3D Printing Competition

Construction firm, 3D printer manufacturer, or both? No matter its formal category, the Austin-based construction technology company ICON is, above all, at the forefront of the digital possibilities of additive...

Featured

GE to Invest Nearly $500M in US Manufacturing, Including 3D Printing

In the latest signal that the pillars of US industrial output are serious about building on last year’s growing momentum to reshore the nation’s manufacturing, GE announced that it plans...

COBOD Machines 3D Printing a House a Week in Kenya

COBOD, the Danish additive construction (AC) firm, has announced that the company’s printers are being used in Kenya to create the world’s largest community of printed affordable housing — topping...

Is 3D Concrete Printing Making its Mark on Commercial Construction?

What do schools in Africa, record-tall wind turbines, disaster-resilient army dwellings, hotels made of sand, and construction projects on the moon all have in common? If you said “3D printing,”...