AH Plus Endodontic Sealer

AH Plus Endodontic Sealer is a two-component epoxy-amine resin paste used for permanent obturation (sealing) of root canals in secondary (baby) teeth in combination with root canal points. It is available in two delivery forms: tubes for manual mixing or a dual-barrel syringe with an intraoral mixing tip for more convenient, precise application.

The proposed device is similar to the predicate in design, mode of action, and composition—both are epoxy-amine paste mixtures. Key differences are minor: composition adjustments for raw material availability and paste stability, and the addition of a dual-barrel syringe delivery system with a mixing tip alongside the traditional tube packaging. Both have 2-year shelf life, are non-sterile, and are applied to the root canal.

ISO 6876:2012 (Dentistry—Root canal sealing materials) for performance testing; ISO 10993 series (ISO 7405:2018, ISO 10993-1:2018, ISO 10993-18:2020, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-3:2014, ISO 10993-6:2016) for biocompatibility; and USP <151> Pyrogen Test.

The proposed device has identical indications for use, intended purpose, and fundamental epoxy-amine chemistry as the predicate K960548. Minor composition variations stem only from raw material sourcing and stability improvements, not fundamental redesign. The additional syringe delivery option does not change the final mixed product or its performance. Bench testing per ISO 6876:2012 confirmed equivalent radiopacity, solubility, setting time, film thickness, and flow; biocompatibility testing per current ISO 10993 standards met all requirements. No new safety or effectiveness concerns were raised by these minor variations.