510(k) Report

Devices descending from K970339

283 later devices reach Tri Auto ZX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170275Tri Auto ZX2J. Morita USA, Inc.20178—
+1K123582Endo a ClassSaeyang Microtech Co., Ltd.20133—
+1K112665Tri Auto Mini - Endodeontic Treatment Motorized HandpieceJ. Morita USA, Inc.20121—
+1K092833Endomax Cordless Endodontic HandpieceDentamerica20104—
+1K090931Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo MotorW&H Dentalwerk Buermoos GmbH200911—
+1K022147Denta PortJ. Morita USA, Inc.200216—
+1K012511Waterlase MillenniumBiolase Technology, Inc.2002246—
+2K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd.20230—
+2K210475EQ-MMeta Systems Co., Ltd.20220—
+2K203320Endo MotorGuilin Woodpecker Medical Instrument Co., Ltd.20211—
+2K192649Endo MotorFoshan Cicada Dental Instrument Co, Ltd.20210—
+2K201993E-connect S Endo Motor with built-in Apex LocatorChangzhou Sifary Medical Technology Co., Ltd.20214—
+2K191276Dental Electrical Motor iRoot ProChangzhou Bomedent Medical Technology Co.,Ltd20200—
+2K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH20152—
+2K143411Traus EndoSaeshin Precision Co., Ltd.20151—
+2K100600Prosthodontic Screwdriver , Model IA-400W&H Dentalwerk Buermoos GmbH20102—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K042822TCM Endo V, Model 1534Nouvag AG20046—
+2K030523WaterlaseBiolase Technology, Inc.20048—
+2K031204Dentaport ZXJ. Morita USA, Inc.200315—
+2K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+3K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.20250—
+3K220829Endo MotorFoshan Coxo Medical Instrument Co., Ltd.20232—
+3K222548Endo MotorShenzhen Perfect Medical Instruments Co., Ltd.20230—
+3K212043Traus EndoSaeshin Precision Co., Ltd.20220—
+3K163402NLZ Motor SystemNakanishi, Inc.20171—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K123608Endo E ClassSaeyang Microtech Co., Ltd.20131—
+3K110278Cordless Prosthodontic Screwdriver with Torque Calibration System, Model ISD900Nakanishi, Inc.20121—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K091922Waterlase C100, Model 7100104Biolase Technology, Inc.20090—
+3K081191TCM Endo 20Nouvag AG20080—
+3K081589Waterlase, Version 3.0Biolase Technology, Inc.20081—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K071190Root ZX IIJ. Morita USA, Inc.20076—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K052515SiroendoSirona Dental Systems GmbH20060—
+3K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+4K251701Star E900 Electric SystemDentalez, Inc., Stardental Division20260—
+4K252223Alpha Endo Handpiece (Alpha Endo)Shenzhen Superline Technology CO., LTD.20250—
+4K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.20250—
+4K213477Root ZX3J. Morita USA, Inc.20220—
+4K161500Meg-TorqMicro-Nx Co., Ltd.20170—
+4K141482KI-20Saeyang Microtech Co., Ltd.20150—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc.20092—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+5K244060eCO2 3DLutronic Corporation20250—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K171867Dr’s Finder NEOGood Doctors Co., Ltd.20180—
+5K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+5K151274Dr's FinderGood Doctors Co., Ltd.20161—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K073411LiteduoLight Instruments20081—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+6K221761SoleaConvergent Dental, Inc.202201
+6K193656SkyPulseFotona D.O.O.202011—
+6K173827LightScalpelLightscalpel, LLC20180—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K173285Joule SystemSciton, Inc20185—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K132976AdvatxAdvalight Aps20141—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K081352Profile Multi-Platform SystemSciton, Inc2008112—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—