LED固化灯（C01-X，C02-X）
K号: K250009 · 2025-04-10
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决定日期2025-04-10
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
LED Curing Light (C01-X, C02-X) is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plus (Dongguan) Limited. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250009. 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 LED Curing Light (C01-X, C02-X)?
LED Curing Light (C01-X, C02-X) is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Premium Plus (Dongguan) Limited. The 510(k) number is K250009.
When did LED Curing Light (C01-X, C02-X) receive FDA 510(k) clearance?
LED Curing Light (C01-X, C02-X) received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250009.
Who is the listed applicant for LED Curing Light (C01-X, C02-X)?
The FDA 510(k) record lists Premium Plus (Dongguan) Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LED Curing Light (C01-X, C02-X)?
The FDA product code for LED Curing Light (C01-X, C02-X) is EBZ.
相关临床试验
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列明Premium Plus (Dongguan) Limited为申报人的其他记录
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。
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。
K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED固化灯（DB686 HALO）Foshan Coxo Medical Instrument Co., Ltd.K241238LOOP™ 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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