Cleared Traditional

ZenSeal Pro

K252890 · Kerr Corporation · Dental
Jan 2026
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K252890 is an FDA 510(k) clearance for the ZenSeal Pro, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Kerr Corporation (Pomona, US). The FDA issued a Cleared decision on January 7, 2026, 118 days after receiving the submission on September 11, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K252890 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2025
Decision Date January 07, 2026
Days to Decision 118 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820