Alpha Endo Handpiece (Alpha Endo)

FDA 510(k) K252223 · Shenzhen Superline Technology Co., Ltd.

Substantially Equivalent

510(k) numberK252223

Submission

Device name
Alpha Endo Handpiece (Alpha Endo)
Applicant
Shenzhen Superline Technology Co., Ltd.
Shenzhen, CN
Received
July 16, 2025
Decision date
October 16, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EKX – Handpiece, Direct Drive, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

When was Alpha Endo Handpiece (Alpha Endo) cleared by the FDA?

Alpha Endo Handpiece (Alpha Endo) (K252223) received a 510(k) decision of Substantially Equivalent on October 16, 2025, 92 days after the submission was received.

What is the product code of K252223?

The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.