| K-number | K252890 |
| Device name | ZenSeal Pro |
| Applicant | Kerr Corporation |
| Product code | KIF |
| Device class | Class II |
| Decision date | Jan 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.3820 |
ZenSeal Pro is a bioceramic root canal sealer based on calcium silicate, delivered as a premixed white cement paste in a single-use syringe with disposable tips. It is intended for permanent obturation of the root canal following removal of infected or necrotic pulp tissue, and is suitable for use in warm vertical condensation, single cone, cold lateral condensation, and gutta-percha carrier obturator techniques.
ZenSeal Pro is an insoluble, radiopaque material that requires water to set and harden. It differs from predicates in chemical composition and product configuration, but shares identical intended use, delivery system, principle of operation, packaging, shelf life (2 years), and similar performance values for flowability, setting time, film thickness, solubility, radiopacity, pH, and heat compatibility.
ISO 6876:2012 (root canal sealing materials), ISO 10993 series (parts 1, 3, 5, 6, 10, 11, 23), ISO 7405:2018 (biocompatibility of dental devices), ISO 13116:2014 (radiopacity testing), and ISO 4049:2019 (restorative dental materials).
ZenSeal Pro is substantially equivalent to predicate devices (CeraSeal K190503 and iRoot SP K080917) because it has the same indications for use, regulatory classification, product code, and principle of operation. Performance testing shows comparable flowability, setting time, film thickness, solubility, radiopacity, and pH values. Biocompatibility testing demonstrates equivalent safety, and clinical validation in 112 teeth across three obturation techniques confirmed safety and efficacy without raising new safety concerns.
View the full FDA submission: accessdata.fda.gov