Graphy Clears EU Review for Five Dental Materials
Korean 3D printing firm Graphy completed final EU Medical Device Regulation review for five dental printing materials, pending certificate issuance.
Updated on Nov. 11, 2026 in Materials Science
Graphy Inc., a KOSDAQ-listed company, announced it has completed the final conformity assessment review under the EU Medical Device Regulation for five dental 3D printing materials, including TeraHarz Clear and TeraHarz dental materials. The company is awaiting issuance of the certificates for the five materials.
Why it matters
EU Medical Device Regulation clearance is a prerequisite for selling medical-grade dental materials in the European market, and the milestone positions Graphy to expand European manufacturing and distribution. It also supports the company's push to commercialize direct 3D-printed Shape Memory Aligners, which it describes as a first in the industry.
The five cleared products are dental 3D printing resins, including TeraHarz Clear and TeraHarz dental materials, used in direct-printed clear aligners. The announcement did not disclose specific mechanical or chemical performance specifications.
The players
Graphy Inc.
A Seoul-based company listed on the KOSDAQ under ticker 318060 that develops direct 3D-printed dental materials and Shape Memory Aligners.
Biotech Dental
A France-based dental company that is the parent of Smilers, the clear aligner brand Graphy is collaborating with.
The details
Graphy announced via PRNewswire on November 10, 2026, that the materials completed the final conformity assessment review under the EU Medical Device Regulation. The company, dateline Seoul, said it is also collaborating with Smilers, the clear aligner brand of France-based Biotech Dental.
Timeline
Nov. 10, 2026: Graphy announces completion of the final EU MDR conformity review for five materials.
Market Landscape
Graphy's direct-printed Shape Memory Aligners are positioned as the first commercial product of their kind, extending the company's lead into regulated European dental markets. Regulatory clearance in the EU is a key step as manufacturers compete to replace traditional thermoformed aligner production with direct printing.
Once certificates are issued, dental professionals and patients in the European Union may gain access to these printed clear aligner materials. Pricing and availability for individual patients have not been announced.
The takeaway
Regulatory clearance is often the gating step between a promising dental material and a product patients can actually use. Watching for issued certificates will show whether Graphy's direct-printed aligner strategy moves into European clinics.
Further reading
For related developments, explore Materials Science coverage of advanced polymers and manufacturing materials.
