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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K200330
Device Name RC-Prime Root Canal Preparation Cream
Applicant
Pac-Dent, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Applicant Contact Daniel Wang
Correspondent
Pac-Dent, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Correspondent Contact Daisy Ni
Classification Product Code
KJJ  
Date Received02/10/2020
Decision Date 07/06/2020
Decision Substantially Equivalent (SESE)
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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