510(k) Report

Devices descending from K003422

65 later devices reach Edta Root Canal Cleanser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032361Endopure Root Canal CleanserDentsply Intl.200464—
+2K071363Waterlase and Waterlase MDBiolase Technology, Inc.200828—
+2K053167Biopure Mtad Root Canal CleanserDentsply Intl., Inc.200563—
+3K193357V-MixInter-Med/Vista Dental Products20201—
+3K123538Epien Root Canal CleanserEpien Medical, Inc.20130—
+3K112250CHX=CHX PlusInter-Med, Inc.20111—
+3K103244Qmix 2IN1 Endodontic Irrigating SolutionDentsply Intl., Inc.20117—
+3K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+3K092232Modification to:Vashe Wound Cleansing System, Model 9000-0014Puricore, Inc.200916—
+3K091922Waterlase C100, Model 7100104Biolase Technology, Inc.20090—
+3K090181Waterlase MDBiolase Technology, Inc.200926—
+3K070401Endo-CHXEssential Dental Systems, Inc.20072—
+3K061689Aquatine EC Endodontic CleanserPuricore, Inc.200611—
+3K060901Vashe Wound Cleansing SystemSterilox Technologies, Inc.20060—
+4K211813TritonInter-Med / Vista Dental20210—
+4K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products20202—
+4K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+4K161669Waterlase ExpressBiolase, Inc.201621—
+4K160577PacEndo ChlorhexidinePac-Dent International, Inc.20160—
+4K150020Irritrol, EDS Combo-RinseEssential Dental Systesm, Inc.20150—
+4K141352Endocyn Root Canal Irrigation SolutionOculus Innovative Sciences20140—
+4K140846Eds Combo-RinseEssential Dental Systems, Inc.20140—
+4K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd.201215—
+4K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+4K082470Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension…Inter-Med, Inc.200967
+5K213428EdgeProBiolase, Inc.20210—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+5K173163ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc.20180—
+5K150664NeoLasSheaumann Laser, Inc.20151—
+5K151852PacEndo Sodium HyprochloritePac-Dent International, Inc.20150—
+5K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+5K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+5K130180Cleanser Root CanalCerkamed Wojciech Pawlowski20130—
+6K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+6K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+7K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+9K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+9K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+10K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+10K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—