510(k) Report

Devices descending from K060328

61 later devices reach Planmeca Promax 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151137X-View, ImagenEdlen Imaging, LLC20160—
+1K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A.2011271
+1K103689Planmeca Promax 3D MidPlanmeca Oy20110—
+1K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY201021—
+1K093590Planmeca Promax 3D MaxPlanmeca Oy201015—
+1K073696VeraviewepocsJ. Morita USA, Inc.200822—
+1K073350Scanora 3DSoredex Palodex Group OY200724—
+2K211159eco-x Series (eco-x, eco-x-s)Hdx Will Corp.20210—
+2K160140DENTRIa seriesHdx Will Corp.20169—
+2K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy20167—
+2K130443I-Max Touch 3DOwandy201321
+2K122981Rayscan a-Expert 3DRay Co., Ltd.201324—
+2K122806Image Works PanouraMic International20132—
+2K122018OP300Palodex Group OY20128—
+2K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd.201111—
+2K110839Scanora 3DSoredex Palodex Group OY20114—
+3K230985Planmeca VisoPlanmeca Oy20233—
+3K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp.20211—
+3K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.20191—
+3K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp.20181—
+3K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark…Villa Sistemi Medicali S.P.A.20181—
+3K181576Planmeca VisoPlanmeca Oy20184—
+3K181136CS 9600Trophy201811
+3K163423Orthopantomograph OP300Palodex Group OY201721
+3K160525RCT700Ray Co., Ltd.201611—
+3K142247Rayscan a-Expert 3DRay Co., Ltd.201522—
+3K133544OP300Palodex Group OY20147—
+3K131695Rayscan a-Expert 3DRay Co., Ltd.201323—
+3K130297Scanora 3DXPalodex Group OY20130—
+3K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+3K121800Point 500 HD POINT500C HDPointnix Co., Ltd.20130—
+4K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+4K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.20260—
+4K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+4K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+4K230505Orthopantomograph™ OP 3D LXPalodex Group OY20231—
+4K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.20200—
+4K200183CS 9600Trophy202001
+4K182614RCT700Ray Co., Ltd.20186—
+4K181452RCT800Ray Co., Ltd.201810—
+4K180947Orthopantomograph OP 3DPalodex Group OY201821
+4K171012Veraview X800J. Morita USA, Inc.20171—
+4K170813Orthopantomograph OP 3DPalodex Group OY201701
+4K161881PreXion3D ExcelsiorPrexion Corporation20162—
+4K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+5K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+5K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY20240—
+5K213226RCT700Ray Co., Ltd.20215—
+5K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+5K2013783D Accuitomo 150NJ. Morita USA, Inc.20210—
+5K182805RCT800Ray Co., Ltd.20188—
+5K173878PreXion3D ExcelsiorPrexion Corporation20181—
+6K251798RCT700Ray Co., Ltd.20250—
+6K243903RCT600Ray Co., Ltd.20250—
+6K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.20250—
+6K230753RCT800Ray Co., Ltd.20231—
+6K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+6K192737RCT800Ray Co., Ltd.20197—
+6K181983PreXion 3D ExcelsiorPrexion Corporation20180—
+7K260462RCT800Ray Co., Ltd.20260—
+7K222219R2 Studio Q/RCT820Megagen Implant Co., Ltd.20220—