Cleared Traditional

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

K242514 · Shenzhen Rogin Medical Co., Ltd. · Dental

Apr 2025

Decision

244d

Days

Class 1

Risk

About This 510(k) Submission

K242514 is an FDA 510(k) clearance for the Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO), a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Shenzhen Rogin Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 24, 2025, 244 days after receiving the submission on August 23, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K242514 FDA.gov
FDA Decision	Cleared 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