Cleared Traditional

K242514 - Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (FDA 510(k) Clearance)

Class I Dental device.

K242514 · Shenzhen Rogin Medical Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
244d
Days
Class 1
Risk

K242514 is an FDA 510(k) clearance for the Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO). Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Shenzhen Rogin Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 24, 2025 after a review of 244 days - an extended review cycle.

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 Rogin Medical Co., Ltd. devices

Submission Details

510(k) Number K242514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2024
Decision Date April 24, 2025
Days to Decision 244 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
117d slower than avg
Panel avg: 127d · This submission: 244d
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 Consultant

Imd Medical & Drug Technology Service Institutions
Salon Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 88
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K242514.
Alpha Endo Handpiece (Alpha Endo)
K252223 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Oct 2025
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EnDrive (EnDriveUS)
K243692 · Advanced Technology Research (A.T.R.) S.R.L. · Aug 2025
ChecQ (AC100)
K241065 · Dentis Co., Ltd. · Mar 2025
HPR Cordless Hygiene Handpiece
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The Trust
K222688 · Genoss Co., Ltd. · Aug 2024