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

Name: FDA 510(k) clearance K242514
Creator: U.S. Food and Drug Administration
Published: 2025-04-24

Substantially Equivalent

Shenzhen Rogin Medical Co., Ltd.

FDA 510(k) clearance K242514 for Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO), Substantially Equivalent on 2025-04-24. Applicant: Shenzhen Rogin Medical Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shenzhen Rogin Medical Co., Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2024-08-23
Decision date: 2025-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.