Compliant, Validated, and the Highest Quality

We did not have much of a digital pathway before we purchased an Asiga MAX 3D printer a few years ago. We intended to use the printer primarily for restorative models, so the expectation was not for it to be a huge source of revenue. Restorative models—along with surgical guides—typically end up in the garbage.

However, we discovered a revenue stream from a direct-print application when our dealer representative sent us a bottle of KeySplint Soft from Keystone Industries along with the Asiga MAX. We had always fabricated bite splints traditionally, but we were really satisfied with the results of the printed material when compared with our traditional splints. There was a bit of a learning curve because making adjustments to a printed splint can be time-consuming and expensive, but once we mastered the process, we translated almost 90% of our splint business to digital methods. The digital process removes so many variables—such as polymerization shrinkage and expansion/contraction of gypsum materials—that we can more efficiently produce perfect-fitting devices.

When Keystone Industries introduced KeySplint Hard, that gave us the ability to produce digital bite splints for any case, even those that required more rigid appliances. We already knew how to design, handle, and post-process KeySplint Soft, so integrating KeySplint Hard was really seamless. It is essentially the same high-quality material, just with slightly different characteristics.

As impressive as the physical characteristics of both materials are, perhaps the most important factors are regulatory compliance and validations. Regulatory compliance is not just handing in some forms and saying, "These are our processes." Manufacturers must go through very rigorous testing to prove that these materials are doing what they claim to do—safely. Bite splints are ultimately medical devices that are staying in people's mouths for extended periods of time, and these resins have various chemicals in their formulations, so you need to be certain that they are safe for patients. Additionally, even an approved material can be incorrectly processed, so printer validations are critical. If the printer settings are incorrect, then the device may not fit well. If it is not properly cured, then it may not be safe in the patient's mouth.

Keystone Industries places a heavy emphasis on compliance with various regulatory organizations, including the FDA and Health Canada, and they have validations not only with Asiga systems but many others as well, so we can be comfortable and confident that we are providing patients with the highest-quality products.

As serendipitous as our foray into 3D printed splints was, I cannot imagine going back to traditional fabrication methods now.

Key Takeaways

› 3D printing bite splints can be a strong revenue stream

› Digitally produced bite splints typically fit better because several variables are eliminated

› KeySplint Soft and KeySplint Hard cover the full range of bite splint applications

› The KeySplint family is FDA 510(k)-cleared, CE marked (Class IIa), and Health Canada approved

About the Author

Minh Tran
Dental Laboratory Technician
Essex Dental Laboratory
Windsor, Ontario

Founder/Creative Director
DentalTechTips

Manufacturing Information
Keystone Industries
keyprint.keystoneindustries.com
800-333-3131

Disclaimer: The statements and opinions contained in the preceding material are not of the editors, publisher, or the Editorial Board of Inside Dental Technology.