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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K251869
Device Name Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
Applicant
Premium Plus (Dongguan) Limited
Flat 101, #122, Tianqiao Rd., Changping
Dongguan,  CN 523581
Applicant Contact Jessica Mao
Correspondent
Premium Plus (Dongguan) Limited
Flat 101, #122, Tianqiao Rd., Changping
Dongguan,  CN 523581
Correspondent Contact Jessica Mao
Regulation Number872.4200
Classification Product Code
EGS  
Date Received06/18/2025
Decision Date 09/15/2025
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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