Cleared Traditional

Light Cure Composite (K240112) - FDA 510(k) Clearance

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

K240112 · Sincera Technology (Changchun) Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
59d
Days
Class 2
Risk

K240112 is an FDA 510(k) clearance for the Light Cure Composite. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sincera Technology (Changchun) Co., Ltd. (Changchun, CN). The FDA issued a Cleared decision on March 15, 2024 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Sincera Technology (Changchun) Co., Ltd. devices

Submission Details

510(k) Number K240112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2024
Decision Date March 15, 2024
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 127d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 291
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K240112.
C&B NFH Hybrid
K232559 · Arum Dentistry Co., Ltd. · Sep 2024
els extra low shrinkage® composite & els extra low shrinkage® flow
K240823 · Saremco Dental AG · Jun 2024
Temporis, Irix Plus
K231142 · Dws S.R.L. · Apr 2024
FORMA Composite (Shade A3D)
K240694 · Ultradent Products, Inc. · Mar 2024
Fusion Core DC Flo
K231263 · Prevest Denpro Limited · Jan 2024
TopCEM Dual Cure Resin Cement
K233082 · Rizhao Huge Biomaterials Company, Ltd. · Dec 2023