Cristaline Aligners Z FLX

Cristaline Aligners Z FLX are clear, removable plastic trays designed to correct tooth misalignment in patients with permanent teeth. Each aligner applies gentle, continuous force over 1-2 weeks to progressively reposition teeth, and patients wear them approximately 22 hours daily except during eating.

The device uses the same thermoplastic co-polyester polyurethane composite material as the predicate device's Z FLX aligner. It employs the same commercially available Blue Sky Plan treatment planning software and similar industry-standard manufacturing processes involving 3D-printed dental models and thermoforming of plastic sheets.

Testing was conducted according to ISO 10993-1 (Biological evaluation of medical devices) at a GLP-certified laboratory, including in vitro cytotoxicity (Part 5), oral mucosal irritation (Part 10), and skin sensitization (Part 10). Bench testing validated manufacturing accuracy of final aligners compared to digital scans.

The device is substantially equivalent because it shares identical materials, identical treatment planning software, and the same indications for use as the predicate. The manufacturing processes, while proprietary to each manufacturer, use standard industry techniques and similar equipment. Since the thermoplastic material composition and software are unchanged from the predicate, and differences in manufacturing methods do not raise new safety or effectiveness concerns, substantial equivalence is established.