Pearl Clear Aligner

The Pearl Clear Aligner is a series of removable, customized clear thermoplastic trays designed to align teeth during orthodontic treatment of malocclusions. Each aligner applies continuous gentle forces over 1-2 weeks, and patients progress through sequential trays prescribed by their dentist/orthodontist to achieve the planned tooth corrections.

The device uses biocompatible thermoplastic polyurethane material identical to the predicate aligner. Aligners are fabricated by vacuum-forming plastic sheets onto 3D-printed dental models derived from the patient's digital scan, using commercially available treatment planning software. While the specific manufacturing processes are proprietary, they employ industry-standard equipment and materials similar to the predicate.

Testing was performed according to ISO 10993 (Biological evaluation of medical devices – Part 1), including in vitro cytotoxicity, oral mucosal irritation, skin sensitization, acute and subacute systemic toxicity, implantation, and subchronic toxicity. Pyrogen testing followed USP 45/NF40. Bench testing validated manufacturing accuracy against initial digital scans.

The device is substantially equivalent because it shares identical intended use (tooth alignment via continuous gentle forces), same classification regulation (21 CFR 872.5470), identical material (thermoplastic polyurethane), equivalent design principle (removable customized trays), and similar manufacturing processes. Differences in proprietary software and fabrication methods do not raise new safety or effectiveness questions, as all testing demonstrates biocompatibility and functional equivalence to the predicate device.