Any-Com Seal

Any-Com Seal is a light-cured pit and fissure sealant designed to seal pits and fissures on tooth surfaces to help prevent dental caries. It consists of a resin-based matrix containing fluoride-releasing micro-hybrid fillers that polymerize when exposed to visible light from a dental curing unit, forming a hardened protective barrier over tooth surfaces.

The device is light-cured (same as predicate), has a depth of cure ≥1.5mm, film thickness ≤50 μm, water sorption ≤40 μg/mm³, solubility ≤7.5 μg/mm³, and is delivered via syringe with disposable tip. It has a 2-year shelf life and is intended for permanent use. Materials include Bis-GMA, TEGDMA, and UDMA with fluoride-releasing fillers.

ISO 4049 and ISO 6874 for performance testing; ISO 10993-1, ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021, and ISO 10993-11:2017 for biocompatibility evaluation including cytotoxicity, irritation, skin sensitization, and systemic toxicity testing.

The subject device has the same indications for use (prophylactic sealing of pits and fissures and micro-restorative procedures), same intended user (licensed dentist), same curing mechanism (light-cured), and substantially similar technological characteristics as the Parkell Pit and Fissure Sealant predicate device (K243254). Performance and biocompatibility test results demonstrate safety and effectiveness equivalent to the predicate, despite minor differences in raw materials.