Clear Miracle

Clear Miracle is a methacrylate-based resin used to create clear, light-cured orthodontic aligners for treating tooth malocclusions in patients with permanent dentition. The device is supplied in 250-gram bottles and is cured by ultraviolet light at 405–412 nanometers to form high-precision aligners through additive manufacturing. It is intended for professional dental use only.

Clear Miracle uses additive manufacturing with a Phrozen Sonic Mini 8K 3D printer and identical methacrylate-based resin composition to the predicate device TERA HARZ CLEAR (K223355). The device forms 50-micrometer-thick layers with 0.022 mm resolution in X and Y axes. Performance testing under ISO 20795-2:2013 shows superior ultimate flexural strength (99–105 MPa vs. 62–67 MPa) and flexural modulus (1,629–1,924 MPa vs. 1,545–1,595 MPa), though with lower solubility (0–1.0 μg/mm³ vs. 1.5–2.1 μg/mm³) and slightly higher water sorption.

ISO 20795-2:2013 (Dentistry – Base Polymers – Part 2: Orthodontic Base Polymers); ISO 10993-1:2018 and ISO 7405:2018 for biocompatibility; ISO 10993-5, ISO 10993-10/23, and ISO 10993-6 for cytotoxicity, irritation, and implantation testing.

The device is substantially equivalent because it shares identical material composition (methacrylate-based resin), manufacturing technology (additive manufacturing), intended use (treating malocclusions in permanent dentition with sequential gentle force), and indications for use with the predicate. Testing demonstrates compliance with the same ISO 20795-2 performance standards with superior or equivalent mechanical properties and biocompatibility. No new safety or efficacy risks were identified compared to the predicate device.