One-Fil Putty Injectable

One-Fil Putty Injectable is a premixed, ready-to-use bioceramic root canal filling material based on tricalcium silicate composition that sets and hardens in the presence of moisture. It is indicated for permanent root canal filling in procedures including furcation/root perforation treatment, internal/external reabsorption treatment, retrofilling, pulp capping, apexification, and pulpotomy.

Both the subject device (One-Fil Putty Injectable) and predicate device (One-Fil Putty) contain identical raw materials: zirconium oxide 40%, tricalcium aluminate compounds 42%, and hydrophilic polymer 18% as thickening agents. The primary difference is particle size of the raw material. Both are premixed ready-to-use pastes with setting times under 1 hour and conform to ISO 6876 performance standards.

ISO 6876 for performance characteristics including curing time, solubility, pH, and radiopacity. FDA Biocompatibility Guidance based on ISO 10993-1 (biological evaluation of medical devices) and ISO 7405 (evaluation of biocompatibility of dental devices).

The subject device is substantially equivalent because it shares identical indications for use, the same base raw material composition, and the same technological approach (tricalcium silicate hydration) as the predicate device. Although particle size differs, performance testing conducted per ISO 6876 demonstrates equivalent performance specifications (curing time 54 min vs 53 min, pH 13.06 vs 12.79, radiopacity 9.20 vs 10.81, solubility 1.1% vs 1.3%), and biocompatibility was established using internationally recognized standards.