Curing Light (M-Cure 6)
K号: K253131 · 2026-06-18
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决定日期2026-06-18
产品代码EBZ
咨询委员会DE
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：EBZ）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED固化灯（DB686 HALO）Foshan Coxo Medical Instrument Co., Ltd.K250009LED固化灯（C01-X，C02-X）Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLCK223414Curing Light，型号：MaxCure 9Guilin Refine Medical Instrument Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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