Cleared Traditional

Curing Light (M-Cure 6) (K253131) - FDA 510(k) Clearance

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

K253131 · Guangzhou Rebornendo Medical Instrument Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
266d
Days
Class 2
Risk

K253131 is an FDA 510(k) clearance for the Curing Light (M-Cure 6). Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Guangzhou Rebornendo Medical Instrument Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on June 18, 2026 after a review of 266 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 Guangzhou Rebornendo Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K253131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2025
Decision Date June 18, 2026
Days to Decision 266 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
139d slower than avg
Panel avg: 127d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 43
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K253131.
Demi Pro
K253461 · Meta Systems Co., Ltd. · Oct 2025
Bluemoon
K242386 · Genoss Co., Ltd. · May 2025
LED Curing Lights (DB686 HALO)
K243921 · Foshan Coxo Medical Instrument Co., Ltd. · Apr 2025
LED Curing Light (C01-X, C02-X)
K250009 · Premium Plus (Dongguan) Limited · Apr 2025
LOOP™ LED Curing Light System (CLK01)
K241238 · Garrison Dental Solutions, LLC · Aug 2024
Curing Light, Model: MaxCure 9
K223414 · Guilin Refine Medical Instrument Co., Ltd. · Nov 2023