FDA 510(k)

“FLNT 基础”和“FLNT 临时”

K号: K253380 · 2026-03-02

决定日期2026-03-02

产品代码EBG

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决定实质等同

器械摘要

“FLNT Base” and “FLNT Temp” is the device name listed in this FDA 510(k) record. The listed applicant is Liaoning Upcera Co., Ltd.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K253380. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the “FLNT Base” and “FLNT Temp”?

“FLNT Base” and “FLNT Temp” is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Liaoning Upcera Co., Ltd.. The 510(k) number is K253380.

When did “FLNT Base” and “FLNT Temp” receive FDA 510(k) clearance?

“FLNT Base” and “FLNT Temp” received FDA 510(k) clearance on 2026-03-02, under 510(k) number K253380.

Who is the listed applicant for “FLNT Base” and “FLNT Temp”?

The FDA 510(k) record lists Liaoning Upcera Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “FLNT Base” and “FLNT Temp”?

The FDA product code for “FLNT Base” and “FLNT Temp” is EBG.

列明Liaoning Upcera Co., Ltd.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。

K253973Gradual 钛酸锆牙冠空白 - GT(F) P1，GT(F) P2 和 SP 系列 K240153陶瓷蚀刻剂（HF-5 和 HF-9）K231687Gradual 钛酸锆牙冠空白 K181167Upcera 釉料膏，釉料粉，和釉料液体 K162323牙齿着色树脂材料

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。

器械摘要

常见问题

列明Liaoning Upcera Co., Ltd.为申报人的其他记录

相关器械（代码：EBG）

官方来源