ReminGel

ReminGel is a premixed, ready-to-use aqueous gel containing suspended hydroxyapatite and calcium/phosphate salts that relieves dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets. It works by remineralizing tooth structure through tubule occlusion and blocking nerve excitability via potassium release. The product is packaged in a 3oz tube for both prescription and over-the-counter use.

ReminGel uses hydroxyapatite formation for tubule occlusion, compared to the predicate device Super Seal which uses oxalate precipitate formation. Both employ potassium ion release to block neural transmission and both are aqueous-based, non-sterile gels with a 2-year shelf life. ReminGel requires 3–15 minutes of application versus Super Seal's 5 seconds, and can be applied via dental trays or toothbrush rather than direct cotton pellet application.

ISO 7405:2018 (biocompatibility evaluation); ISO 10993-1:2018 (biological evaluation and risk management); ISO 10993-5:2009 (in vitro cytotoxicity); ISO 10993-10:2021 (skin sensitization); ISO 10993-23:2021 (irritation testing); ISO 14971:2019 (risk management); ISO 15223-1:2021 (labeling symbols); ISO 11014:2009 (safety data sheets); ISO 20417:2021 (manufacturer-supplied information).

ReminGel is substantially equivalent to Super Seal because both are Class II cavity varnishes with identical indications for use, intended patient population, anatomical site, and primary mechanism of action (tubule occlusion). Although ReminGel uses hydroxyapatite formation instead of oxalate precipitate, both formulations employ potassium salts to block neural transmission and achieve the same clinical outcome. Non-clinical testing demonstrates ReminGel achieves comparable or superior tubule occlusion, exhibits better cytotoxicity results, and passes all relevant biocompatibility testing; the differences in composition, application method, and packaging do not raise safety or efficacy concerns.