Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive

The Ormco EtchFree Bonding System is an orthodontic bonding system consisting of a primer, sealant, and adhesive used to attach orthodontic appliances (metal brackets, ceramic brackets, and aligner attachments) to tooth enamel without requiring phosphoric acid etching. The primer conditions the tooth surface, and the adhesive bonds the brackets to teeth.

The subject primer and adhesive are biocompatible composite materials with appropriate bond strength for orthodontic applications. Both use light-curing photoinitiation and are packaged for multi-patient use. Minor differences include: the subject primer does not bond to dentin (unlike predicates), uses different filler types for viscosity and bond strength, and is offered only in 4-gram syringes versus predicate's multiple package sizes. Curing times differ slightly between devices but are attributable to different light sources and intensities.

ISO 29022 (shear bond strength), ISO 11405:2015 (adhesion to tooth structure), ASTM F2503-23 (MRI safety), ASTM F1980-16 (aging of sterile barriers), ISO 15223-1 (device symbols), ANSI/AAMI ISO 14971:2019 (risk management), ISO 7405 and ANSI/AAMI ISO 10993 series (biocompatibility testing including cytotoxicity, sensitization, irritation, and genotoxicity).

The subject devices have identical intended uses as their predicates—bonding orthodontic appliances to enamel. Both subject and predicate devices are biocompatible composites with equivalent bond strengths, use light-curing, and function through similar principles. Although there are minor compositional and packaging differences, these do not affect safety or efficacy; all differences in curing times are attributable to different light sources and intensities rather than device design. Non-clinical testing demonstrates performance equivalence across all relevant parameters.