Cleared Traditional

K242530 - HF-Etchant Hydrofluoric Acid Etching Gel

K242530 is an FDA 510(k) clearance for HF-Etchant Hydrofluoric Acid Etching Gel, manufactured by Rizhao Huge Biomaterials Company, Ltd.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K242530 · Rizhao Huge Biomaterials Company, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
116d
Days
Class 2
Risk

K242530 is an FDA 510(k) clearance for the HF-Etchant Hydrofluoric Acid Etching Gel. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN). The FDA issued a Cleared decision on December 20, 2024 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Rizhao Huge Biomaterials Company, Ltd. devices

FDA 510(k) Submission Details - K242530

510(k) Number K242530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 127d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K242530.
els unibond
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K252469 · Dmp Dental Industry S.A. · Nov 2025
G-Bond Universal
K251124 · GC America, Inc. · Oct 2025
TopCEM Ceramic Primer Ceramic Coupling Agent
K242749 · Rizhao Huge Biomaterials Company, Ltd. · Nov 2024
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
K242675 · Spident Co., Ltd. · Nov 2024
Ceramic Etchant (HF-5 and HF-9)
K240153 · Liaoning Upcera Co., Ltd. · Oct 2024