Injectable Root Canal Bioceramic Sealer (nRoot SP)

The nRoot SP is a premixed, ready-to-use injectable white hydraulic cement paste composed of calcium silicate for permanent root canal filling and sealing. It is supplied in preloaded syringes with disposable intracanal tips in five sizes (0.5g, 1g, 2g, 3g, 5g) and can be delivered via disposable tips or traditional methods. The device is used for permanent obturation following vital pulp extirpation or removal of infected/necrotic pulp, and is suitable for single cone and lateral condensation techniques.

The proposed device has the same basic design and delivery mechanism as the predicate (single-paste formulation in preloaded syringes with intracanal tips). The chemical composition is similar, containing zirconium dioxide, calcium silicates, calcium hydroxide, and thickening agents, compared to the predicate's zirconium oxide, strontium silicates, calcium phosphates, calcium hydroxide, tantalum oxide, and filler agents. Both products have a 2-year shelf life and are non-sterile with identical indications for use.

ISO 6876:2012 (Dentistry - Root canal sealing materials) and ISO 10993-1 (Biological evaluation of medical devices). ISO 7405 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry) was also cited. Bench testing included appearance, loading capacity, flow, working time, setting time, film thickness, dimensional change following setting, solubility and disintegration, radio-opacity, pH, heavy metal content, and microorganism testing.

The device is substantially equivalent because it is essentially identical to predicate K240304 in intended use, design, delivery mechanism, and performance standards. Both are single-paste injectable root canal sealers with the same indications, use in identical clinical applications, and comparable chemical compositions meeting ISO 6876. Non-clinical test results for appearance, flow, setting time, dimensional change, radio-opacity, pH, and biocompatibility are very similar to the predicate, demonstrating equivalent safety and effectiveness despite minor compositional differences in filler materials.