LOS ANGELES, CALIF. (PRWEB) - The FDA has officially approved a 510(k) for the use of DENTCA's new 3D printable material as a denture base.
Dr. Jason Lee, creator of the technology, says: “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. 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. DENTCA already revolutionized the fit of dentures by directly scanning the impressions instead of the need to pour a stone; now it will further increase it by removing the need for a flask in the future market, thus significantly reducing distortion.”
Fabrication of dental prosthetics with DENTCA Denture Base utilizes a CAD/CAM software system, specialized tray impression systems, and a digital denture file database the system automates the denture making process almost to perfection. Now by also incorporating an optical impression system, a stereolithographic additive printer, and curing light equipment, it finally closes a cycle for success, giving the doctor a completely evolved denture manufacture process.
The material has passed al recent biocompatibility tests placed in evaluation for the DENTCA Denture Base in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1, as recognized by FDA. The battery of testing included tests for Genotoxicity, Cytotoxicity, Sensitization, Irritation, Acute Toxicity & Material Characterization which the printable material passed with flying colors. Declaring the 3D printable material for considered tissue contacting for a period longer than 30 days (a removable prosthesis). DENTCA Denture Base was tested for conformity with the industry consensus standard ISO 20795-1.
DENTCA CEO Sun Kwon says: “This clearance completely revolutionizes the denture manufacture process, which has barely changed in over 100 years. 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.”