Cleared Traditional

K252223 - Alpha Endo Handpiece (Alpha Endo)

K252223 is an FDA 510(k) clearance for Alpha Endo Handpiece (Alpha Endo), manufactured by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K252223 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
92d
Days
Class 1
Risk

K252223 is an FDA 510(k) clearance for the Alpha Endo Handpiece (Alpha Endo). Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2025 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. devices

FDA 510(k) Submission Details - K252223

510(k) Number K252223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 45
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