510(k) Report

Devices descending from K160140

9 later devices reach DENTRIa series through their predicates, nearest generation first.

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