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| A 3-D printer fabricating dentures made using the Dentca Denture Base--Courtesy of Dentca |
Dentca announced that it received the first FDA clearance for a 3-D printed resin that's used as the base material during the denture repair and fabrication process.
The regulatory move marks the continued advent of 3-D printing as a method of manufacturing medical devices and comes around the same time as the FDA approved its first 3-D printed drug.
In its clearance letter, the FDA described the denture fabrication process, saying it "begins with a traditional casting impression of the oral region in the dentist office. This impression is sent to a dental lab for conversion to digital image in an optical impression system. The denture base is then made layer-by-layer in a stereolithographic laser printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment."
"Layer-by-layer" refers to the 3-D printing process, also known as additive manufacturing.
Production of dentures using the Dentca Denture Base requires a computer-aided design and computer-aided manufacturing (CAD/CAM) system, which includes an oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment, says the FDA. Those components are not part of the device.
The Dentca was deemed substantially equivalent to the Dentsply Trubyte Denture Base Resin System. The only difference between the two base materials is that Dentca's is applied using automated 3-D printing, while Dentsply's is manually applied, the clearance letter says.
"This clearance completely revolutionizes the denture manufacture process, which has barely changed in over 100 years," said Dentca CEO Sun Kwon in a statement. "The new developments will create incredible possibilities for patients, as doctors will soon be able to 3-D print final dentures at their office, allowing the manufacture process to be done in one day everywhere in the world."
SmarTech Markets Publishing estimates that dental hardware, materials, and components enabled by 3D printing will constitute a $2 billion market in 2016, rising to $3.1 billion by 2020.
- read the clearance letter (PDF)
- here's the release