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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 K240707
Device Name Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
Applicant
Shenzhen Micro Electric Intelligence Co., Ltd.
301, Bldg. A5, # 13 Baonan Rd., Longgang Community
Longgang District
Shenzhen,  CN 518100
Applicant Contact Fengmeng Han
Correspondent
Shenzhen Micro Electric Intelligence Co., Ltd.
301, Bldg. A5, # 13 Baonan Rd., Longgang Community
Longgang District
Shenzhen,  CN 518100
Correspondent Contact Fengmeng Han
Regulation Number872.4850
Classification Product Code
ELC  
Date Received03/15/2024
Decision Date 07/02/2024
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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