Curing Light (M-Cure 6)— 510(k) K253131

Name: FDA 510(k) clearance K253131
Creator: U.S. Food and Drug Administration
Published: 2026-06-18

Substantially Equivalent

Guangzhou Rebornendo Medical Instrument Co., Ltd.

FDA 510(k) clearance K253131 for Curing Light (M-Cure 6), Substantially Equivalent on 2026-06-18. Applicant: Guangzhou Rebornendo Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Rebornendo Medical Instrument Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2025-09-25
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBZ

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K253461 — Demi Pro2025-10-14
K242386 — Bluemoon2025-05-05
K243921 — LED Curing Lights (DB686 HALO)2025-04-11
K250009 — LED Curing Light (C01-X, C02-X)2025-04-10
K241238 — LOOP LED Curing Light System (CLK01)2024-08-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.