MEM Clear Aligner System

The MEM Clear Aligner System is a customized orthodontic device consisting of a series of transparent, removable plastic aligners designed to treat tooth malocclusion in patients with permanent dentition. The aligners reposition teeth gradually through continuous gentle force, with each aligner worn sequentially for approximately 2 weeks at 20-22 hours per day as prescribed by a dental practitioner.

The device is manufactured using thermoforming technology from thermoplastic polymer materials, resulting in removable aligners custom-designed using 3Shape A/S software. Key mechanical properties include ultimate flexural strength of 50–110 MPa, flexural modulus of 1500–1950 MPa, Shore D hardness ≥40 Hd, and water sorption of 0.43–0.58% per ASTM D570.

Biocompatibility testing per ISO 10993-3 (genotoxicity), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-6 (subcutaneous implantation), ISO 10993-10 (skin irritation and sensitization), ISO 10993-11 (acute and subacute systemic toxicity, pyrogenicity), ISO 10993-12 (extract), and ISO 10993-23 (oral mucosa irritation). Mechanical properties tested per ISO 20795-2:2013 and ASTM D570.

The MEM Clear Aligner System shares the same intended use, mode of action, principles of operation, method of use, duration, manufacturing method, and removable application as the predicate device (ULab Systems Dental Aligner Kit, K192596). Both devices are Class II orthodontic plastic brackets using thermoforming to create sequential aligners for continuous gentle force tooth repositioning. Comprehensive biocompatibility and mechanical testing demonstrates that material and performance differences do not raise new safety or effectiveness concerns, establishing substantial equivalence.