Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)

i-MTA BP is a ready-to-use premixed bioceramic paste for permanent root canal sealing and repair. It is aluminum-free, based on calcium silicate composition, requires moisture to set, does not shrink during setting, and is packaged in a preloaded syringe. It is indicated for root perforation repair, root resorption repair, root end filling, apexification, and pulp capping.

The subject device uses calcium silicate, zirconium oxide, tantalum pentoxide, calcium sulfate and filler agents, whereas the predicate C-Root BP uses strontium silicate, calcium phosphates, calcium hydroxide, and tantalum oxide. Both are insoluble, radiopaque bioceramics that set in the presence of moisture. The subject device shares identical formulation, processing, and final form with the reference device iRoot BP Plus, using all the same raw materials.

ISO 6876:2012 for setting time, solubility, and radio-opacity; ISO 6876:2001 for size change after curing; ISO 10993-1, ISO 7405, and FDA guidance for biocompatibility; ISO 7405:2018 for cytotoxicity and pulp capping testing; ISO 10993-10:2021 for sensitization and irritation; ISO 10993-11:2017 for acute and subchronic systemic toxicity; ISO 10993-3:2014 for genotoxicity; ISO 10993-6:2016 for implantation testing.

The device has identical indications for use and principle of operation as the predicate. Although chemical composition differs (calcium vs. strontium silicates, calcium sulfate vs. calcium phosphates/hydroxide), these are functionally equivalent material classes—both silicates and calcium salts that set and harden upon moisture exposure. Performance testing demonstrates substantially equivalent physical properties: setting time (2.5h vs. requirement 2-6h), solubility (2.80% vs. <3%), and radio-opacity (>3mm Al). Biocompatibility testing across ten ISO/IEC endpoints shows compliance. The subject device's formulation, processing, and constituent materials are identical to the cleared reference device iRoot BP Plus.