Well-Root PT

Well-Root PT is a ready-to-use, premixed bioceramic paste containing calcium silicate cement, liquid, and compound particles delivered in capsules. It is intended for pulp capping, root canal repair and filling, repair of root perforations and resorption, root-end filling, and apexification procedures. The material sets in the root without requiring mixing with additional water.

Well-Root PT differs from the primary predicate (ProRoot MTA) in delivery form—single premixed paste versus powder requiring manual mixing—and setting time (25 minutes versus 4–6 hours at 37°C). It matches the reference predicate (iRoot BP Plus) in single-paste delivery form but sets faster (25 minutes versus 2 hours). All three are non-sterile, single-use materials based on calcium silicate compositions and conform to ISO 6876.

ISO 6876 (root canal filling materials—radio-opacity, film thickness, solubility/disintegration, setting time); ISO 10993 series for biocompatibility (cytotoxicity, sensitization, oral mucosa irritation, acute systemic toxicity, bacterial reverse mutation, and implantation).

Well-Root PT has identical indications for use and the same principle of operation (calcium silicate-based bioceramic paste that sets without external water mixing) as both predicates. Although delivery and setting time differ from ProRoot MTA, these are user-convenience attributes that do not affect safety or effectiveness, and test results satisfy ISO 6876 requirements. The reference predicate (iRoot BP Plus) demonstrates that a single-paste calcium silicate formulation with faster setting is already substantially equivalent. Bench and biocompatibility testing show no new safety concerns from the technological differences.