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Keystone Industries Statement on Safety and Compliance of KeyPrint® Dental 3D Printing Resins

Recent Study of Non-Keystone Resins for Ovo-Toxicity is Inapplicable to KeyPrint Resins

February 18, 2021

Gibbstown, New Jersey

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 and were not included in this Study and to emphasize the safety and efficacy of Keystone’s 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 the very limited scope of the Study, the Study’s title inaccurately suggests a broader application of their work across all dental 3D printing materials, including those never tested or assessed by the investigators.

Second, the raw ingredient identified by the Study that that triggered concerns about ovo-toxicity (Tinuvin 292) is not contained in any of Keystone’s KeyPrint formulations.

Third, the two resins actually 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 our products to ensure that they are safe and effective for their intended uses by dental professionals and their patients.

About Keystone Industries

Keystone’s group of dental companies focuses largely on consumable digital, laboratory, operatory, and preventative products. The company is a global supplier, maintaining a diverse network of more than 800 U.S. and international dental distribution partners in 70+ countries.

Keystone has developed industry-leading products such as its innovative KeyPrint line of 3D printing resins, Diamond D® high-impact denture base, and the Pro-Form® line of thermoplastics, innovative and patent-protected laboratory offerings such as Enamelite ceramic spray glazes, and the award-winning Gelato prophy paste. Keystone has spent nearly three decades formulating and producing biocompatible, cutting-edge, patented photopolymer resins for dental and cosmetic nail applications. Keystone maintains FDA licensing, ISO 13485 (medical device) and 22716 certifications, along with GMP certification and international product registrations.

To learn more, visit https://dental.keystoneindustries.com, like the Keystone Facebook page, or follow Keystone on Instagram and Twitter.

Keystone Industries and Nexa3D join forces to deliver higher productivity and performance 3D printing solutions for the dental industry

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