Home / 510(k) Clearances / K242514

510(k) K242514

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) by Shenzhen Rogin Medical Co., Ltd. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2025
Date Received
August 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Shenzhen Rogin Medical Co., Ltd.

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