FDA approves 3D printable denture base material
“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.
New system from DENTCA has the chance to totally change the denture workflow.
The FDA has officially approved a 510(k) for the use of DENTCA’s new 3D printable material as a denture base that has the possibility of revolutionizing the denture-making world.
Dr. Jason Lee is the creator of this technology and 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 manufacturing 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 computer-aided design and manufacturing (CAD/CAM) software system, specialized tray impression systems, and a digital denture file database. The system automates the denture-making process, and now by also incorporating an optical impression system, a stereolithographic additive printer and curing light equipment, it closes a cycle for success, giving the dental professional a completely evolved denture manufacture process.
The material has passed a 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.
For more information, visit dentca.com or call 855-433-6822
