Cleared Traditional

HF-Etchant Hydrofluoric Acid Etching Gel

K242530 · Rizhao Huge Biomaterials Company, Ltd. · Dental
Dec 2024
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K242530 is an FDA 510(k) clearance for the HF-Etchant Hydrofluoric Acid Etching Gel, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN). The FDA issued a Cleared decision on December 20, 2024, 116 days after receiving the submission on August 26, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K242530 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2024
Decision Date December 20, 2024
Days to Decision 116 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200