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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K260275
Device Name Mobile Dental Solution (Model: DS50, DS70, DS90)
Applicant
Guangdong JINME Medical Technology Co., Ltd.
Rm. 301, 401, 501, Block #3, Wanyang Science Park
84 Taoyuan E. Rd. Shishan Town, Nanhai District
Foshan,  CN
Applicant Contact Ying Yang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number872.6640
Classification Product Code
EIA  
Subsequent Product Code
SJH  
Date Received01/29/2026
Decision Date 10/23/2026
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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