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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 K240950
Device Name Disposable Prophy Angle
Applicant
Pacific Care Limited
Unit 308-309, 15w, Hong Kong Science Park
N.T.,  HK
Applicant Contact Chris Kwong
Correspondent
Pacific Care Limited
Unit 308-309, 15w, Hong Kong Science Park
N.T.,  HK
Correspondent Contact Chris Kwong
Regulation Number872.4200
Classification Product Code
EGS  
Date Received04/08/2024
Decision Date 05/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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