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510(k) K201785

Device
EPIEN Dental Cleanser
Applicant
EPIEN Medical, Inc.
510(k) number
K201785
Product code
KJJ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-09
Date received
2020-06-30
Regulation
510(k) Premarket Notification
Classification name
Cleanser, Root Canal
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Reginald Dupre
Address
4225 White Bear Pkwy. Suite 600 St. Paul MN US 55110 55110

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
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
K200330RC-Prime Root Canal Preparation CreamPac-Dent, Inc.2020-07-06
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

Legacy Summary#

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FDA Review#

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