Parkell Pit and Fissure Sealant

The Parkell Pit and Fissure Sealant is a light-cured, flowable, resin-based dental sealant indicated for prophylactic sealing of pits and fissures and micro-restorative procedures for composite restorations. It is delivered via a 1.2 mL syringe and contains filling agents that release and recharge beneficial ions (fluoride and calcium). The device is intended for use by licensed healthcare professionals only.

The device is a low-viscosity paste with light-cure polymerization (20-second cure time), light-curable at standard power (600 mW/cm²). Key physical properties include bond strength to dry enamel ≥10 MPa, compressive strength ≥200 MPa, flexural strength ≥90 MPa, depth of cure 1.5–2.5 mm, shrinkage ≤8%, and viscosity 1–5 Pa·s. It comes with an applicator tip and has a two-year shelf life.

Not stated in this summary. The document references non-clinical physical property testing but does not cite specific consensus standards (ISO, IEC, ASTM, etc.) by number or name.

The Parkell device is substantially equivalent to the Premier Sealant (K#161580) because both share identical intended use (prophylactic pit-and-fissure sealing and micro-restorative procedures), same product code (EBC) and regulation (21 CFR 872.3765), identical material form (low-viscosity paste), identical polymerization method and curing time (light-cure, 20 seconds), same delivery system (1.2 mL syringe), and all critical physical properties meet or exceed the same pass/fail criteria. Both devices are substantially equivalent in chemical composition and biocompatibility, with the Parkell device containing the same types of beneficial ions (fluoride and calcium) as the predicate.