Cleared Traditional

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) (K242675) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242675 · Spident Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
56d
Days
Class 2
Risk

K242675 is an FDA 510(k) clearance for the FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5.... Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Spident Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on November 1, 2024 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spident Co., Ltd. devices

Submission Details

510(k) Number K242675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2024
Decision Date November 01, 2024
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 121
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K242675.
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K242530 · Rizhao Huge Biomaterials Company, Ltd. · Dec 2024
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K242749 · Rizhao Huge Biomaterials Company, Ltd. · Nov 2024
Ceramic Etchant (HF-5 and HF-9)
K240153 · Liaoning Upcera Co., Ltd. · Oct 2024
K-Bond Universal
K241445 · Spident Co., Ltd. · Jul 2024
Light Cure Adhesive
K241056 · Sincera Technology (Changchun) Co., Ltd. · Jul 2024