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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K242514
Device Name Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
Applicant
Shenzhen Rogin Medical Co., Ltd.
Rm. 3109, Block 6, Tian'An Cloud Park,
Bantian St., Longgang District
Shenzhen,  CN 518129
Applicant Contact Salon Chen
Correspondent
Imd Medical & Drug Technology Service Institutions
Rm. 308, Bldg. 11, # 23 Jinqu Rd., Wanjiang District
Dongguan,  CN 523039
Correspondent Contact Salon Chen
Regulation Number872.4200
Classification Product Code
EKX  
Date Received08/23/2024
Decision Date 04/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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