Cleared Traditional

K252223 - Alpha Endo Handpiece (Alpha Endo) (FDA 510(k) Clearance)

Class I Dental device.

K252223 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Dental device
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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

Submission Details

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.

Device Classification

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 88
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