Cleared Abbreviated

Parkell Pit and Fissure Sealant

K243254 · Parkell, Inc. · Dental
Aug 2025
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K243254 is an FDA 510(k) clearance for the Parkell Pit and Fissure Sealant, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on August 8, 2025, 297 days after receiving the submission on October 15, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K243254 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2024
Decision Date August 08, 2025
Days to Decision 297 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBC — Sealant, Pit And Fissure, And Conditioner
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3765

Similar Devices — EBC Sealant, Pit And Fissure, And Conditioner

All 129
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
K232498 · Ultradent Product, Inc. · Aug 2023
Enamel Coating Resin
K230455 · Rizhao Huge Biomaterials Company, Ltd. · Jul 2023
BA Pit & Fissure Sealant
K190998 · Apex Dental Materials, Inc. · Nov 2019
Helioseal F Plus
K190339 · Ivoclar Vivadent, AG · Jul 2019
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · Pulpdent Corporation · Jan 2018
Nanova Sealant
K171330 · Nanova Biomaterials, Inc. · Sep 2017