Keystone Industries recently obtained 510k clearance from the U.S. FDA to sell its 3D printing night guard and splint resin, KeySplint Soft, in the United States. The material is already available in Canada and the EU.
Without being brittle, KeySplint Soft is tough and durable like a hard splint to withstand the forces of bruxism, but also flexible for patient comfort, according to a press release. It is abrasion and fracture resistant, has three years of guaranteed shelf life, and offers an efficient, profitable way to make splints and night guards.
KeySplint Soft is available in two shades: an esthetic clear version that is exclusively optimized for the Carbon® Digital Manufacturing Platform, making the material available to Carbon’s global network of dental partners and customers, and an open-source version with a slight violet tint.
The combination of KeySplint Soft Clear resin and Carbon’s M series printers allows labs to produce 6 times more splints than traditional production methods while increasing profit per unit by nearly 75%, according to the release.
Keystone Industries has validated KeySplint Soft in several printers and with several post-cure units, including printers from Carbon, Asiga, MiiCraft and others, with additional validations ongoing regularly.
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Source: Keystone Industries