510(k) Report

Devices descending from K032361

64 later devices reach Endopure Root Canal Cleanser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071363Waterlase and Waterlase MDBiolase Technology, Inc.200828—
+1K053167Biopure Mtad Root Canal CleanserDentsply Intl., Inc.200563—
+2K193357V-MixInter-Med/Vista Dental Products20201—
+2K123538Epien Root Canal CleanserEpien Medical, Inc.20130—
+2K112250CHX=CHX PlusInter-Med, Inc.20111—
+2K103244Qmix 2IN1 Endodontic Irrigating SolutionDentsply Intl., Inc.20117—
+2K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+2K092232Modification to:Vashe Wound Cleansing System, Model 9000-0014Puricore, Inc.200916—
+2K091922Waterlase C100, Model 7100104Biolase Technology, Inc.20090—
+2K090181Waterlase MDBiolase Technology, Inc.200926—
+2K070401Endo-CHXEssential Dental Systems, Inc.20072—
+2K061689Aquatine EC Endodontic CleanserPuricore, Inc.200611—
+2K060901Vashe Wound Cleansing SystemSterilox Technologies, Inc.20060—
+3K211813TritonInter-Med / Vista Dental20210—
+3K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products20202—
+3K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+3K161669Waterlase ExpressBiolase, Inc.201621—
+3K160577PacEndo ChlorhexidinePac-Dent International, Inc.20160—
+3K150020Irritrol, EDS Combo-RinseEssential Dental Systesm, Inc.20150—
+3K141352Endocyn Root Canal Irrigation SolutionOculus Innovative Sciences20140—
+3K140846Eds Combo-RinseEssential Dental Systems, Inc.20140—
+3K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd.201215—
+3K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+3K082470Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension…Inter-Med, Inc.200967
+4K213428EdgeProBiolase, Inc.20210—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+4K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+4K173163ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc.20180—
+4K150664NeoLasSheaumann Laser, Inc.20151—
+4K151852PacEndo Sodium HyprochloritePac-Dent International, Inc.20150—
+4K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+4K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+4K130180Cleanser Root CanalCerkamed Wojciech Pawlowski20130—
+5K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+5K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+6K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+8K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+8K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+9K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+9K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—