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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Portable Dental Operative Unit
510(k) Number K254009
Device Name Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
Applicant
Lakong Medical Devices Co., Ltd.
#13 Jingci Rd., Shilong
Dongguan,  CN 523326
Applicant Contact Zhongliang Wang
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 805, #19 Dongbao Rd., Songjiang Area
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number872.6640
Classification Product Code
SJH  
Date Received12/15/2025
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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