510(k) Report

Devices descending from DEN990002

51 later devices reach Kavo Diagnodent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112139The Canary SystemQuantum Dental Technologies, Inc.20120—
+1K090598Cariescan ProCariescan, Ltd.20091—
+1K073074Key Laser Iii 1243 US with DetectKavo America200826—
+1K051909DiagnodentKavo America200529—
+1K042394Diagnodent Perio Tip (Accessory)Kavo America Corporation200528—
+1K043156D-Carie, Model N121-M1Neks Technologies, Inc.20051—
+1K040063Inspektor ProInspektor Dental Care BV200413—
+1K023367Detectar, Model N123-MINeks Technologies200331—
+2K221275Qraycam PROAIOBIO Co., Ltd.20240—
+2K231722SmarToothSmartooth Co., Ltd.20240—
+2K170822Electronic Caries DetectorOrtek Therapeutics, Inc.20170—
+2K111423CS 1600 Intraoral CameraCarestream Health, Inc.20120—
+2K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+2K093705FuorecamTherapeutic Technologies, Inc.20100—
+2K092583SoprolifeSopro20103—
+2K090169Spectra Fluorescence Caries Detection DeviceAir Techniques, Inc.20096—
+2K063321D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138Neks Technologies, Inc.20070—
+2K060080Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation200627—
+3K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+3K161669Waterlase ExpressBiolase, Inc.201621—
+3K150672VistaCam iX ProofDurr Dental AG20165—
+3K121685SoprocareSopro20131—
+3K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+4K223470C50Sopro20230—
+4K221249L1P-1F (Trios 5)3Shape TRIOS A/S20221—
+4K213428EdgeProBiolase, Inc.20210—
+4K183471IC-WHCD100 (Inspire)Good Doctors Co., Ltd.20200—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+4K171007Fluorescence ModeCarl Zeiss Suzhou Co., Ltd.20181—
+4K150664NeoLasSheaumann Laser, Inc.20151—
+5K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd.20260—
+5K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+5K242103TRIOS Ready Tip3Shape TRIOS A/S20250—
+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—
+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—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.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—
+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—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—