FDA.reportPublic FDA data

510(k) K250279

Device
RC-SwiftPrep
Applicant
Belport Company, Inc., Gingi-Pak
510(k) number
K250279
Product code
KJJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-02
Date received
2025-01-31
Classification name
Cleanser, Root Canal
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
Peng Jingtian
Address
4825 Calle Alto Camarillo CA US 93012 93012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k), Device, Applicant table
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K200330RC-Prime Root Canal Preparation CreamPac-Dent, Inc.2020-07-06
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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