[Edaily Reporter NA EUN-KYUNG ] #Graphy Inc. is expanding its so-called “tooth printing” business, which involves directly manufacturing dental prosthetics such as crowns and bridges using 3D printers. The company plans to develop “Tera Harz E-namel,” a material for aesthetic prosthetics, into a new growth engine to succeed its flagship product, the shape-memory transparent orthodontic appliance (SMA). Overseas, the company is moving forward with the establishment of a directly operated production lab in Brazil, while in the U.S., it is laying the groundwork for entering the North American market by validating its products with local partners ahead of Food and Drug Administration (FDA) approval.

Local Production Instead of Export… Using Brazil as a Hub for the Americas

According to a recent report from Graphy Inc., the company is pursuing local production

in Brazil

to reduce the burden of tariffs and logistics costs. Judging that it would be difficult to secure price competitiveness in local markets by exporting finished products manufactured in South Korea, the company opted for direct production rather than sales through distributors.

Graphy Inc. has previously completed registration with Brazil’s National Health Surveillance Agency (ANVISA) for five types of dental 3D printing resins used in the production of shape-memory clear aligners and permanent crowns. Based on this, the company plans to directly operate a production lab where it will receive patients’ oral scan data from local dental clinics to develop treatment plans and manufacture and supply orthodontic appliances.

Shim Un-seop, Chairman of Graphy Inc., stated, “Brazil has high tariff burdens, making it difficult to successfully establish a foothold through exports alone,” adding, “Rather than entering into local distribution agreements, Graphy Inc. plans to operate its own production lab.”

Preparations for the establishment are also taking shape. Chairman Shim explained, “We have finished scouting potential locations and are currently selecting personnel to work on-site,” adding, “We are in the stage of preparing for employee recruitment and securing a site.”

The Brazilian hub is expected to be utilized not only for local sales but also for treatment planning and customer support across the Americas. This is because establishing treatment plans based on patient data transmitted from dental clinics requires real-time communication with local medical staff, but there are limitations due to the time difference when responding immediately to customers in the Americas from Korea.

Chairman Shim said, “Brazil is a key hub that allows us to target the South American market while also responding in real time to North American customers,” adding, “This approach ensures greater cost competitiveness than operating all design and support personnel in the U.S.”

In the U.S., the company is currently undergoing the FDA 510(k) clearance process for TerraHertz Enamel, along with verification by local partners. TerraHertz Enamel is an aesthetic prosthetic material used to 3D-print crowns, bridges, and implant crowns.

Chairman Shim said, “Although U.S. approval has not yet been finalized, so partners cannot purchase the product yet, local partners are verifying the product’s performance and practical applicability in advance of approval,” adding, “The response so far has been quite positive.”

Taking on 3D Printing Instead of the Traditional Zirconia Milling and Sintering Method

Graphy Inc. is expanding its business structure—which has focused on clear aligners—into prosthetics, led by TerraHertz Enamel. Conventional zirconia prosthetics involve shaping a hard block or disk into a tooth-like form using milling equipment, followed by firing at high temperatures to enhance strength and durability. In contrast, Graphy Inc.’s method directly prints prosthetics from liquid material tailored to the patient’s oral data, which the company explains reduces material waste and streamlines the manufacturing process.

Chairman Shim also suggested that the prosthetics business has the potential to grow into a larger venture than the company’s current flagship product, shape-memory alloy (SMA) clear aligners.

“Prosthetic materials could actually generate even higher sales than SMA,” he explained, adding, “While orthodontic treatment takes one to two years to show results, prosthetics yield visible results in just a few months and are less subject to seasonal fluctuations compared to orthodontics.”

However, the success of the prosthetics business depends on how quickly dental practices and laboratories adopt new manufacturing methods. Just as zirconia has become widely established in dental practice, it is also necessary to clinically validate the physical properties, aesthetics, and long-term durability of 3D-printing materials.

Chairman Shim emphasized, “Changing the workflow of prosthetic fabrication will have a significant ripple effect, but if we fail to bring about this change, it may amount to nothing more than a storm in a teacup.” He added, “We will expand validation by leading clinicians and dental laboratories and combine training on equipment, materials, and processes to make prosthetics a new growth engine for Graphy Inc.”