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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
Pac-Dent, Inc
670 Endeavor Circle
Brea,  CA  92821
Applicant Contact Daniel Wang
Pac-Dent, Inc
670 Endeavor Circle
Brea,  CA  92821
Correspondent Contact Daisy Ni
Classification Product Code
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