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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K202674
Device Name Medidenta High Speed Handpieces
Applicant
Pac-Dent, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Applicant Contact Jiahe Li
Correspondent
Pac-Dent, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Correspondent Contact Jingtian Peng
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/15/2020
Decision Date 12/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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