Additively Manufactured Aligner Resin

Additively Manufactured Aligner Resin is a light-curing 3D printing resin used to manufacture invisible orthodontic appliances (clear aligners) that gently reposition teeth through continuous force. The resin can also be used to print dental splints and night guards. It is composed of acrylate resin oligomers, monomers, initiators, and additives, supplied as a colorless to yellowish liquid in black HDPE bottles with a 24-month shelf life unopened.

The device uses light-cured 3D printing technology identical to predicate devices, employing polyurethane-based acrylate resin. Testing per ISO 20795-2:2013 showed the subject device has higher flexural modulus (877.49 MPa average vs. 804 ± 64 MPa) and ultimate flexural strength (39.72 MPa vs. 23.6 ± 1.9 MPa) than Predicate Device 1. Water solubility and sorption values differ slightly but remain within ISO standards. The device is removable, prescription-use, worn 20-22 hours daily, and delivers the same mode of action as predicates: sequential gentle force application via preformed plastic trays.

ISO 20795-2:2013 (Dentistry – Base polymers – Part 2: Orthodontic base polymers) for mechanical properties. ISO 10993-1:2018 and ISO 7405:2018 for biocompatibility. Specific biocompatibility tests per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 10993-11 (acute and subchronic systemic toxicity), and ISO 10993-3 (genotoxicity). Shelf-life stability testing documented per validation protocols.

The subject device is substantially equivalent because it shares the same intended use (orthodontic tooth repositioning and splint manufacturing), identical manufacturing method (light-cured 3D printing), same prescription status and removable application, and identical mode of action (continuous gentle force via sequential trays) as the predicates. While mechanical property values differ numerically, all results conform to ISO 20795-2:2013 requirements; the subject device's higher flexural properties represent a performance advantage, not a safety concern. The combined indications—orthodontic treatment from Predicate 1 plus splint/retainer manufacturing from Predicate 2—pose no new safety or effectiveness questions. Comprehensive biocompatibility testing addressing mucosal contact confirms safety parity with legally marketed predicates.