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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 K222548
Device Name Endo Motor
Applicant
Shenzhen Perfect Medical Instruments Co., Ltd.
Rm. 102, Bldg. A, Ruiji Factory, # 3 Zaohekeng,
Jixia Community, Nanwan St., Longgang
Shenzhen,  CN 518100
Applicant Contact Kristy Mo
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number872.4200
Classification Product Code
EKX  
Subsequent Product Code
LQY  
Date Received08/23/2022
Decision Date 04/26/2023
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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