Revolutionizing Night Guard and Splint Technology

“One of the things we set out to do was to create some really innovative direct-printed medical devices for patients,” says Ira Rosenau, Keystone’s President of Dental. “Castables are great and models remain the predominant printed application in dentistry, but the real innovation and the next step in moving this industry forward was to create medical devices that could be printed directly: splints, night guards, dentures, teeth, direct print aligners, etc.”

Keystone identified color stability and brittleness as the primary limitations of most of the splint materials on the market. They set out to create something similar to a dual-laminate, hard-soft guard that would offer strong protection against bruxism, but also be comfortable to wear, without brittleness.

“It took a lot of testing,” says Rosenau, whose company manufactures all of its materials in New Jersey. “Like all things in research and development, there were successes and failures along the way, but ultimately, we developed a product that is very innovative and different from anything else on the market.”

KeySplint Soft wears as long as, if not longer than, traditional splint materials, Rosenau says.

“We are particularly gratified that our early users are really thrilled with the quality, uniqueness, comfort, and protection of the device,” he says. “Additionally, laboratories love the value. Each of these KeySplint devices brings significant profit.”

In an independent study by Mark A. Latta, DMD, MS, KeySplint Soft was found to have a unique modulus that “will likely result in enhanced longevity for the appliance” as well as unique flexural properties that “at body temperature are more pliable and as a result become more comfortable to wear and yet maintain their shape outside of the mouth.”

Rosenau says the material really stands out for its fracture resistance.

“Adding to the efficiency of 3D printing, this material should be an improvement over traditional acrylics or thermoform materials from a wear and life expectancy standpoint,” he says.

Part of the process of bringing this revolutionary product to the market was gaining FDA clearance, something Keystone believes is supremely important.

“Some companies think getting cleared through other territories alone is sufficient, but we do not share that view; we think it is an application that requires 510(k) clearance,” Rosenau says. “The expense and time involved with gaining FDA clearance is significant, and the FDA is still wrestling with 3D printing for medical devices. I expect there to be more materials cleared in the future, but until then, we are happy to be one of the two resins currently approved for this application in the US.”

Both versions of the KeySplint material are translucent; the open-source version has a very light tint. Rosenau explains that the tint is present for technological reasons involving having the material print consistently on several validated printers.

“We need the end product to be the same coming out of every printer and cure box,” Rosenau says. “At the end of the validated workflow, we want an apple-to-apple-to-apple comparison of physical properties and biocompatibility. Not every printer is the same, so this is part of making the material more universal.”

Still, Keystone wanted to create a clear formula for KeySplint Soft, and chose to optimize that with Carbon.

“With the throughput of the Carbon machines, users will be absolutely thrilled,” Rosenau says. “Several high-volume users in Canada and Europe already have been using the material and are getting fantastic results.”

Keystone’s team worked closely with Carbon for nearly 2 years to optimize Carbon’s complex hardware and software systems with the KeySplint Soft Clear material.

“Their team is very dedicated,” Rosenau says. “The two companies have gotten to know each other very well, and we are motivated jointly to see this combination succeed for dental professionals and patients.”

As part of its global strategy with Carbon, Keystone sought an efficient supply solution through Henry Schein and its 35+ international subsidiaries.

“We really needed a global strategy for fulfillment,” Rosenau says. “We have excellent distribution partners in the US, but on a global basis, only one partner fit the fulfillment needs of this project.”

Rosenau says to expect more from Keystone in the near future.

“In the next 2 months,” he says, “you will see some really interesting news from us about partnerships, validations, and materials.”

For now, however, he expects KeySplint Soft to be revolutionary for laboratories.

“Whether from a quality perspective or a value perspective, it delivers on both fronts in spades,” he says. “It is off-the-charts game-changing.”