Cleared Traditional

Enamel Coating Resin

K230455 · Rizhao Huge Biomaterials Company, Ltd. · Dental
Jul 2023
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K230455 is an FDA 510(k) clearance for the Enamel Coating Resin, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao City, CN). The FDA issued a Cleared decision on July 25, 2023, 154 days after receiving the submission on February 21, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K230455 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2023
Decision Date July 25, 2023
Days to Decision 154 days
Submission Type Traditional
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
Parkell Pit and Fissure Sealant
K243254 · Parkell, Inc. · Aug 2025
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
K232498 · Ultradent Product, Inc. · Aug 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