Flexible Partial Resin

Flexible Partial Resin is a light-cured polymerizable resin used to fabricate removable partial denture bases and other dental appliances (such as dental plates, bite plates, partial denture frameworks, and clasps) in dental laboratories. The resin is designed for use with DLP printers at 385nm wavelength and is available in three pink shades (G1, G3, G4) to match gingival tissue. The finished appliances are custom-fitted to patient oral anatomy per dental professional prescription.

The subject device uses methacrylate/dimethacrylate-based resin with photo-initiator, stabilizer, fillers, and pigments, compared to the predicate's polyamide material. Both employ CAD/CAM fabrication for patient-specific removable appliances; the key difference is manufacturing method: the subject device is 3D-printed using a compatible DLP printer, while the predicate device is milled from pre-manufactured blocks. The different material composition does not affect safety and effectiveness.

ASTM D790 (flexural strength and modulus), ASTM D638 (tensile strength and elongation), ASTM D256 (impact strength), ASTM D570 (water absorption), ISO 10993-1:2018 (biocompatibility), and ISO 20795-1:2013 (water sorption and solubility). Printing accuracy testing validated that samples printed at 0°, 45°, and 90° angles met design specifications within tolerance.

The subject device meets the same acceptance criteria as the predicate across all physical property tests (flexural strength, tensile strength, elongation, impact strength, water absorption), demonstrating equivalent performance. The indications for use are identical—dental appliances including plates, bite plates, frameworks, and clasps. Although the manufacturing method differs (3D printing vs. milling), both devices use biocompatible materials, achieve the same clinical function of creating custom-fitted removable dental prostheses, and demonstrate no biocompatibility concerns. The printing accuracy and orientation validation confirm reliable fabrication across the build space.