510(k) Report

Devices descending from K093590

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211159eco-x Series (eco-x, eco-x-s)Hdx Will Corp.20210—
+1K160140DENTRIa seriesHdx Will Corp.20169—
+1K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy20167—
+1K103689Planmeca Promax 3D MidPlanmeca Oy20110—
+2K230985Planmeca VisoPlanmeca Oy20233—
+2K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp.20211—
+2K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp.20181—
+2K181576Planmeca VisoPlanmeca Oy20184—
+2K181136CS 9600Trophy201811
+3K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+3K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.20260—
+3K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+3K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.20200—
+3K200183CS 9600Trophy202001
+4K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—