LuxCreo Clear Aligner System

The LuxCreo Clear Aligner System is a custom clear plastic orthodontic device consisting of a series of removable aligners that treat tooth malocclusion (misalignment) in patients with permanent dentition. The aligners apply continuous gentle force to reposition teeth incrementally from their original state to the desired treated state, worn for approximately 20–22 hours per day as prescribed by a dental professional.

The proposed device uses light-cured 3D printing (DLP/SLA technology) with UV-cured medical-grade polyurethane resin, identical manufacturing method to the predicate. Key differences include improved mechanical properties (higher flexural strength of 34.61 MPa vs. 23.6 MPa, higher modulus, and Shore D hardness), lower water solubility and absorption, and extended shelf life of 12 months versus the predicate's 6 months. Both are removable, prescription-only (Rx) devices with the same intended use and mode of operation.

ISO 10993-3:2014 (Genotoxicity), ISO 10993-5 (In vitro Cytotoxicity), ISO 10993-6:2016 (Subcutaneous Implantation), ISO 10993-10 (Oral Mucosa Irritation and Skin Sensitization), ISO 10993-11 (Acute and Sub-chronic Systemic Toxicity), USP Pyrogen Study, ISO 20795-2:2013 (Flexural Modulus). Transportation, accelerating aging, design verification, validation, and manufacturing validation tests were also completed.

Substantial equivalence is supported because the proposed device shares identical indications for use, intended patient population, mode of action (continuous gentle force via sequential aligners), method of use, duration of wear, and manufacturing process (light-cured 3D printing) as the predicate (K212680). Although the material composition differs, comprehensive biocompatibility and mechanical property testing demonstrate equivalent or superior performance; all tests passed with results meeting or exceeding predicate specifications, and the extended shelf life is supported by validated stability and packaging integrity data.