Alpha Endo Handpiece (Alpha Endo)— 510(k) K252223

Name: FDA 510(k) clearance K252223
Creator: U.S. Food and Drug Administration
Published: 2025-10-16

Substantially Equivalent

SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

FDA 510(k) clearance K252223 for Alpha Endo Handpiece (Alpha Endo), Substantially Equivalent on 2025-10-16. Applicant: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. Device class: 1.

Clearance details

Applicant: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2025-07-16
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKX

view all

K261987 — Reusable SmartPeg2026-09-08
K251597 — InnerView System2025-09-18
K243692 — EnDrive (EnDriveUS)2025-08-22
K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)2025-04-24
K241065 — ChecQ (AC100)2025-03-21

More clearances from SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

view all

K242765 — Electronic Apex Locator (Alpha Apex I)2025-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.