[Edaily Reporter NA EUN-KYUNG ] #Graphy Inc. has launched “Tera Harz E-Namel” (R-191), a 3D-printing-based aesthetic prosthetic material, and is expanding its dental prosthetics business.

Graphy Inc. announced on the 15th that it had obtained manufacturing certification on the 7th for “Resin for Dental Crowns” (C07070.01), a Class II medical device in South Korea, for Tera Harz E-Namel. The company has also submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to enter the U.S. market.

Tera Harz E-Namel is a light-curable 3D printing prosthetic material that incorporates 53% inorganic ceramic filler into a polymer matrix. It was developed to enable the direct 3D printing of digitally designed dental restorations, such as crowns, bridges, inlays, and onlays. The company plans to expand its application scope in the future to include implant crowns and “All-on-X” full-arch restorations.

Crown resin is a medical device used to manufacture dental restorations such as permanent crowns and bridges. With this manufacturing certification, Graphy Inc. is now authorized to manufacture and sell TerraHaze E-Enamel as crown resin in South Korea.

Conventional zirconia restorations involve cutting material in the form of blocks or discs and then sintering them. Terahaz E-Enamel, on the other hand, involves directly printing the restoration based on digital design data, followed by post-processing. Graphy Inc. plans to provide not only the material but also 3D printers and post-processing equipment, as well as process training and technical support related to printing and quality control.

Graphy Inc.’s entry into the dental restoration materials business is aimed at expanding the scope of application for the 3D printing material technology it has developed through its core business of clear aligners. Graphy Inc. has commercialized and is currently selling “SMA” (Shape Memory Aligner), a clear aligner manufactured by directly 3D printing photopolymer materials. With this new product, the company has expanded its product lineup from orthodontic aligners to materials used in the fabrication of dental prosthetics.

In the implant sector, Graphy Inc. is also pursuing a partnership with Megagen Implant. Graphy Inc. plans to develop a strategy that links implant treatment with prosthetic fabrication using Terahaz E-Enamel, while combining material supply with support for printing and post-processing. Previously, Graphy Inc. had been pursuing a business partnership with Megagen Implant that included product supply and distribution.

Overseas, the company is undergoing the U.S. approval process. Graphy Inc. has submitted a FDA 510(k) premarket notification for TerraHertz E-Enamel and aims to obtain clearance by the fourth quarter of this year. The FDA 510(k) is a procedure in which a medical device is evaluated for substantial equivalence to an existing, legally marketed product before it can be sold in the United States.

Shim Un-seop, CEO of Graphy Inc., stated, “TerraHaz E-Enamel is a product that extends Graphy Inc.’s accumulated technology in photopolymerizable 3D printing materials from the orthodontic field to the aesthetic prosthetics sector.” He added, “We will expand the scope of application from crowns and bridges to implant crowns and grow our prosthetic materials business by combining equipment, process training, and technical support.”