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United States FDA 510(k) clearance K252223Substantially Equivalent

Alpha Endo Handpiece (Alpha Endo)

United StatesClass 1SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.Cleared Oct 16, 2025
Verified
Clearance details
K-Number
K252223
View FDA 510(k) Summary PDF View on FDA Database
Note: PDF may not be available for all submissions
Product Code
EKX
View Product Code Classification
Device Class
Class 1
Clearance Type
Traditional
Regulation Number
872.4200
View CFR Regulation
Applicant information
Applicant
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Contact
Jinsong Zhou
Location
Rm. 302, Nanshan Zhiyuan A4, #1001 Xueyuan Ave.,
Changyuan Community, Taoyuan St., Nanshan District
Shenzhen 518000
CN
Medical classification
Medical Specialty
Dental
Advisory Committee
DE
Dates and decision
Date Received
Jul 16, 2025
Decision Date
Oct 16, 2025
Decision
Substantially Equivalent
Statement / Summary

Summary

About this record

Access comprehensive regulatory information for Alpha Endo Handpiece (Alpha Endo) in the USA medical device market through Pure Global AI's free database. This Class 1 medical device was cleared under FDA 510(k) number K252223 and submitted by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. The clearance decision was Substantially Equivalent on Oct 16, 2025.

This page provides complete clearance details including product code EKX, medical specialty classification (Dental), and regulatory compliance information from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present, helping global MedTech companies navigate USA FDA regulations efficiently.