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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K242317
Device Name Integrated Endo System (Meet Endo-II)
Applicant
Denjoy Dental Co., Ltd.
F4, Bldg. A4, Lugu Medical Device Park, #229
Guyuan Rd.
Changsha,  CN 410205
Applicant Contact Chengfa Huang
Correspondent
Denjoy Dental Co., Ltd.
F4, Bldg. A4, Lugu Medical Device Park, #229
Guyuan Rd.
Changsha,  CN 410205
Correspondent Contact Chengfa Huang
Regulation Number872.4850
Classification Product Code
ELC  
Subsequent Product Codes
EKR   EKX  
Date Received08/05/2024
Decision Date 02/13/2025
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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