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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 K243130
Device Name Integral Dental Unit
Applicant
Guangdong Yadeng Medical Apparatus Co., Ltd.,
Factory 2, #12, Fenggong Rd., Nansha Industrial Zone,
Danzao Town, Nanhai District
Foshan,  CN 528216
Applicant Contact Chang Ming Weng
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
906 Rm., Longxiang Garden,
Tianhe District
Guangzhou,  CN 510000
Correspondent Contact Jett Lee
Regulation Number872.6640
Classification Product Code
EIA  
Subsequent Product Code
KLC  
Date Received09/30/2024
Decision Date 06/27/2025
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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