Keystone Industries responds to recent study about Dental 3D Printing Resins
Keystone Industries is aware of the recent publication of a study by the Department of Obstetrics and Gynecology at Northwestern University, misleadingly titled, “Dental Resins Used in 3D Printing Technologies Release Ovo-toxic Leachates” (the “Study”).
Keystone Industries believes it is important to clarify what materials were used in this study and to emphasize the safety and efficacy of its dental 3D printing resins.
First, the Study only addressed two materials from one single manufacturer (a dental surgical guide resin and dental LT nightguard resin). No 3D printing materials from Keystone Industries, or any other manufacturers, were studied.
Despite its very limited scope, the Study inaccurately suggests a broader application all dental 3D printing materials, including those never tested or assessed by the investigators.
Second, the raw ingredient identified by the Study that triggered concerns about ovo-toxicity (Tinuvin 292) is not contained in any of Keystone’s KeyPrint formulations.
Third, the two resins assessed in the Study were prepared for use in non-dental applications (using 3D resins to grow reproductive cells), which is not the purpose for which either of those materials were designed.
Finally, neither of the resins tested in the Study have been submitted to, or cleared by, the FDA under the 510k pre-market notification process. By contrast, Keystone’s KeySplint Soft has been reviewed and 510k-cleared for sale in the United States, including the review of the required biocompatibility tests to obtain 510k clearance.
Keystone Industries takes the safety of our products very seriously. Our KeyPrint 3D resins are developed following our ISO-13485 accredited quality management system, following design controls, cGMP, and 21CFR820, to ensure that every product we manufacture is safe and effective for its intended use.
All medical devices requiring submission are reviewed and approved for sale by the FDA through the 510k pre-market notification process. This process includes the required submission, review, and approval of biocompatibility data.
Keystone will continue to rigorously test all of its products to ensure they are safe and effective for their intended uses, both for dental professionals and their patients.
For more information, visit https://dental.keystoneindustries.com