The Food and Drug Administration has given Keystone Industries 510k clearance to sell its KeySplint Soft 3-D printing night guard and splint resin in the United States. Without being brittle, KeySplint is tough and durable like a hard splint to withstand the forces of bruxism yet flexible for patient comfort, Keystone says. Made in the United States, it has three years of guaranteed shelf life, the company adds.
Two shades are available. The open-source version has a slight violet tint. The aesthetic Soft Clear version is optimized exclusively for the Carbon Digital Manufacturing Platform. The combination of the Soft Clear resin and Carbon’s M series 3-D printers allows labs to produce six times more splints than traditional production methods while increasing profit per unit by nearly 75%, Keystone Industries says.
Keystone Industries says that it has validated KeySplint Soft in several printers and with several post-care units, including printers from Carbon, Asiga, and MiiCraft, with additional validations ongoing regularly. KeySplint Soft yields high-quality, accurate, and safe devices at significantly reduced labor and material costs compared to other methods, the company says. And with digital storage available, lost or damaged splints can be reprinted easily without additional rework or patient visits.
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