FDA.reportPublic FDA data

510(k) K200330

Device
RC-Prime Root Canal Preparation Cream
Applicant
Pac-Dent, Inc.
510(k) number
K200330
Product code
KJJ
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-06
Date received
2020-02-10
Classification name
Cleanser, Root Canal
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Daniel Wang
Address
670 Endeavor Cir. Brea CA US 92821 92821

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KJJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250279RC-SwiftPrepBelport Company, Inc., Gingi-Pak2025-07-02
K241354Sealer SolventInter-Med, Inc.2024-08-27
K201785EPIEN Dental CleanserEpien Medical, Inc.2021-09-09
K211813TritonInter-Med / Vista Dental2021-08-18
K193357V-MixInter-Med/Vista Dental Products2020-10-23
K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products2020-09-09
K173163ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc.2018-02-09
K162311Straumann PrefGelInstitut Straumann AG2017-03-07
K160577PacEndo ChlorhexidinePac-Dent International, Inc.2016-07-25
K153528PacEndo EDTAPac-Dent International, Inc.2016-02-01
K151852PacEndo Sodium HyprochloritePac-Dent International, Inc.2015-11-10
K150020Irritrol, EDS Combo-RinseEssential Dental Systesm, Inc.2015-02-25
K141352ENDOCYN ROOT CANAL IRRIGATION SOLUTIONOculus Innovative Sciences2014-08-18
K140846EDS COMBO-RINSEEssential Dental Systems, Inc.2014-07-25
K130180CLEANSER ROOT CANALCerkamed Wojciech Pawlowski2013-10-03