Additive-manufacturing resins for dental restorations: indications and predicate pathways in FDA 510(k) clearances

Introduction: Additive manufacturing (3D printing) resins have expanded rapidly in restorative dentistry, and in the United States they reach the market through the FDA 510(k) pathway based on substantial equivalence to a predicate device. The number of such clearances and the pathways used have not been quantified. Methods: Cross-sectional analysis of the openFDA 510(k) database. All clearances with decision dates from 2018-01-01 to 2026-12-31 in the dental resin product codes for denture base (EBI), permanent tooth-shade (EBF) and temporary crown-and-bridge (EBG and POW) resins were included and classified as additively manufactured or conventionally fabricated using the FDA 510(k) summaries. Results: Of 249 clearances, 84 (33.70%) were additively manufactured resins, comprising 48 denture base, 19 permanent, 16 temporary and 1 long-term temporary resins. Additive clearances rose from 2 in 2018 to between 12 and 14 per year from 2020 onward. The Traditional pathway accounted for 74 clearances (88.10%), the Abbreviated pathway for 9 (10.70%) and the Special pathway for 1 (1.20%); 14 clearances (16.70%) used third-party review. A primary predicate was identifiable for 66 clearances (78.60%), most often NextDent Denture 3D+, Dentca Denture Base II and an early additive CAD/CAM system. Conclusions: Between 2018 and 2026, 3D-printable resins for dental restorations obtained 84 FDA 510(k) clearances, concentrated in denture bases and dominated by the Traditional predicate pathway, with a predicate cascade anchored in early additive-manufacturing devices.