Guangzhou Heygears IMC., Inc. · Class U · Cleared Mar 2, 2026
| K-number | K253798 |
| Device name | UltraPrint-Dental Hard Splint UV |
| Applicant | Guangzhou Heygears IMC., Inc. |
| Product code | MQC |
| Device class | Class U |
| Decision date | Mar 2, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
The UltraPrint-Dental Hard Splint UV is a light-curing, acrylate-based resin designed for 3D printing of dental and orthodontic appliances including mouthguards, nightguards, splints, repositioners, and retainers. It undergoes polymerization under UV-LED light at 385 nm wavelength to form solid dental devices with high flexural strength and modulus.
Both the subject device and predicate (KeyPrint KeySplint Hard) are UV-curable acrylate resins using DLP printing technology with similar material composition (UV curable resin, photo initiator, and pigments). The key difference is the specific chemical formulation, though both meet ISO 20795-2 standards and ISO 10993-1 biocompatibility requirements. Physical/mechanical properties include ultimate flexural strength ≥50 MPa and flexural elastic modulus ≥1500 MPa.
ISO 20795-2:2013 (dental base polymers), ISO 10993 (biocompatibility), ISO 7405 (biocompatibility evaluation), ASTM D790 (flexural strength/modulus), ASTM D2240 (Shore D hardness), ASTM D256 (impact), ASTM F1980-21 (accelerated aging), and AAMI ST98:2022 (cleaning validation).
View the full FDA submission: accessdata.fda.gov