Cleared Traditional

Alpha Endo Handpiece (Alpha Endo)

K252223 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Dental
Oct 2025
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K252223 is an FDA 510(k) clearance for the Alpha Endo Handpiece (Alpha Endo), a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2025, 92 days after receiving the submission on July 16, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K252223 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2025
Decision Date October 16, 2025
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200