One-Fil Putty

One-Fil Putty is a permanent root canal filling and repair material made with tricalcium aluminate compound in a premixed, moisture-hardening formulation. It is supplied as a white paste in glass syringes and is used for various endodontic procedures including furcation/root perforation treatment, reabsorption treatment, pulp capping, apexification, and pulpotomy.

Both the subject device and predicate (BIO-C REPAIR) are self-curing materials hardened by moisture, packaged in syringes, non-sterile, with a 2-year shelf life, and conforming to ISO 6876. The subject device has a faster setting time (53 minutes versus 90–120 minutes) and slightly higher radio-opacity (10.81 versus ~7 mm aluminum equivalent), but both meet the same performance and biocompatibility standards.

ISO 6876 (root canal filling materials—foreign substance, packaging, setting time, solubility, radio-opacity); ISO 13116:2014 (radio-opacity); ISO 10993-5, 10, 11 (biocompatibility); and internal shelf-life testing.

The subject and predicate devices share identical indications for use, the same self-curing mechanism, similar material compositions (both contain zirconium oxide as the primary radiopacifier), and both conform to ISO 6876 for performance and ISO 10993 for biocompatibility. Although the formulations differ (tricalcium aluminate compounds versus calcium silicates), the differences do not raise new safety or efficacy issues because both achieve the required physical, chemical, and biocompatibility properties to support the same clinical applications.