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

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 & More in Fabrication, Materials, Applications for Liquid Metal Antennas

Zhejiang University Sheds Light on APVC with 3D Printed Surgical Models



Categories

3D Design

3D Printed Art

3D Printed Food

3D Printed Guns


You May Also Like

Chinese University of Hong Kong Studies 3D Printing for Heart Disease

In the recently published ‘Three-dimensional printing in structural heart disease and intervention,’ authors Yiting Fan, Randolph H.L. Wong, and Alex Pui-Wai Lee, all from The Chinese University of Hong Kong,...

VA Puget Sound Initiative: Advancing 3D Printing for Heart Disease

For over one hundred years, treating heart disease meant opening the patient’s chest to access the heart through open-heart surgery. The procedure usually takes between three to six hours and...

China: Improving Cell Viability by Refining Structural Design in Scaffolds

Chinese researchers are seeking new ways to create stronger cell growth and sustainability in scaffolds. With their findings outlined in the recently published, ‘Structure-induced cell growth by 3D printing of...

Scientists Use 3D Printed Models to Further Congenital Heart Disease Studies

In the recently published ‘Accurate Congenital Heart Disease Model Generation for 3D Printing,’ researchers explore 3D printing for diagnosis, treatment, and planning in congenital heart disease (CHD) patients. CHD usually...


Shop

View our broad assortment of in house and third party products.


Services & Data

Subscribe To Our Newsletter

Subscribe To Our Newsletter

Join our mailing list to receive the latest news and updates from our 3DPrint.com.

You have Successfully Subscribed!