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FDA 510(k)

Curing Light (M-Cure 6)

K-Number: K253131 · 2026-06-18

ApplicantGuangzhou Rebornendo Medical Instrument Co., Ltd.
Decision Date2026-06-18
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Curing Light (M-Cure 6) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Rebornendo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253131. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Curing Light (M-Cure 6)?

Curing Light (M-Cure 6) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Guangzhou Rebornendo Medical Instrument Co., Ltd.. The 510(k) number is K253131.

When did Curing Light (M-Cure 6) receive FDA 510(k) clearance?

Curing Light (M-Cure 6) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253131.

Who is the listed applicant for Curing Light (M-Cure 6)?

The FDA 510(k) record lists Guangzhou Rebornendo Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Curing Light (M-Cure 6)?

The FDA product code for Curing Light (M-Cure 6) is EBZ.

Related Devices (Code: EBZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLCK223414Curing Light, Model: MaxCure 9Guilin Refine Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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