Composite Orthodontic Brackets and Buttons

The ECC Premium Line consists of composite orthodontic brackets and buttons made of polyurethane that are bonded to teeth to correct dental malocclusions such as misaligned teeth, overcrowding, spacing issues, and bite irregularities. These devices work with wires, adhesives, and other attachments to apply gentle forces that gradually move teeth into their desired positions during orthodontic treatment lasting 6 months to 2.5 years.

The brackets and buttons are made of polyurethane composite material and feature a bracket body with low profile, possibility for hooks on cuspids and bicuspids, and mechanical retention base. They have slots for wires and defined torque, angulation, and rotation values. Buttons are single-wing brackets without torque, angulation, rotation, or hooks. Both are biocompatible plastics with mucosal contact and permanent exposure duration.

ISO 27020:2019 (FR 4-313) for dimensional testing. FDA Guidance on Recommended Content and Format of Non-Clinical Bench Performance Testing. Bench tests performed include dimensional, hardness, shear, friction force, gate pull, torque, wear abrasion, water absorption, and discoloration tests.

The ECC Premium Line fulfills the same technological characteristics as the predicate device (Reflections, K973776): identical bracket design with low profile and mechanical retention, same material composition (polyurethane composite), same categorization under ISO 10993-1:2018, same patient-tissue contact materials, and same clinical characteristics including indications, duration of contact, and patient population. Non-clinical bench testing demonstrates equivalent performance and safety, and the device does not raise new safety or effectiveness issues compared to the predicate.