FDA 510(k)

一次性预防性角度（3399-60，3399-090，3399-105）

K号: K251869 · 2025-09-15

决定日期2025-09-15

产品代码EGS

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决定实质等同

器械摘要

Disposable Prophy Angle (3399-60, 3399-090, 3399-105) 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 2025-09-15 under 510(k) number K251869. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Prophy Angle (3399-60, 3399-090, 3399-105)?

Disposable Prophy Angle (3399-60, 3399-090, 3399-105) is a medical device that received FDA 510(k) clearance on 2025-09-15. The listed applicant is Premium Plus (Dongguan) Limited. The 510(k) number is K251869.

When did Disposable Prophy Angle (3399-60, 3399-090, 3399-105) receive FDA 510(k) clearance?

Disposable Prophy Angle (3399-60, 3399-090, 3399-105) received FDA 510(k) clearance on 2025-09-15, under 510(k) number K251869.

Who is the listed applicant for Disposable Prophy Angle (3399-60, 3399-090, 3399-105)?

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 Disposable Prophy Angle (3399-60, 3399-090, 3399-105)?

The FDA product code for Disposable Prophy Angle (3399-60, 3399-090, 3399-105) is EGS.

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。

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官方来源

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