Dental Device Guide
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Imaging devices · 21 CFR 892

Dental Computed Tomography X-Ray

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

FDA codeOASClass221 CFR892.1750Pathway510(k)CategoryDental CBCT
Companies listing it
3930 makers
Brands and models
146
510(k) clearances
13642 in five years
FDA name
X-Ray, Tomography, Computed, Dental
2001: 12004: 12007: 22008: 22009: 22010: 12011: 62012: 72013: 102014: 52015: 52016: 122017: 42018: 112019: 72020: 92021: 112022: 62023: 122024: 42025: 92026: 919801990200020102020

510(k) clearances per year, 1976–2026

Dental cone-beam CT is classified under Radiology (21 CFR 892.1750), not Dental.

Companies that list OAS

39 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMaker—1482026
Megagen Implant Co., Ltd.South KoreaMakerR2 STUDIO Q · RCT820 · RCT820-SC302026
Osstem Implant Co., Ltd.South KoreaMakerT1 C, T1-CS · T2 (T2-C, T2-CS) · T2 Plus (T2-C-P, T2-CS-P) · T2-C. T2-CS682026
Ray Co., Ltd,South KoreaMakerR2 Studio Q · RAYPreMiere · RAYQuantum · RAYSCAN ?-Expert3D · +12212026
VATECH Co., Ltd.South KoreaMakerGreen X 12 Plus / Green X Plus (Model: PHT-70CHS) · Green X 12 SE (Model : PHT-40CHS) · Green X 21 (Model : PHT-90CHO)332026
Cefla S.C.ItalyMakerEOS Compact · hyperion X5 · hyperion X9 pro · NewTom 5G XL · +8152026
Genoray Co., Ltd.South KoreaMakerGT300 · GT300-C · PAPAYA 3D · PAPAYA 3D Plus · +2142025
Yian Medical Technology (Haining) Co., Ltd.ChinaMakerDental CBCT X-ray System · OAS - X-ray, tomography, computed, dental32025
PaloDEx Group OyFinlandMakerORTHOPANTOMOGRAPH OP 3D · Orthopantomograph OP 3D EX · Orthopantomograph™ OP 3D EX · Orthopantomograph OP 3D LX · +192024
Durr Dental SEGermanyMakerProVecta 3D Prime · ProVecta 3D Prime Ceph · ProVecta 3D Prime with VisionX62023
Alliage S/A Industrias Medico OdontologicaBrazilMakerDENTAL CT SCANNER AXR · Eagle Edge/Dabi Atlante AXR120 · Eagle Edge/Dabi Atlante AXR90 · Evolve/Prexion AXR120 · +632024
Dental Imaging Technologies CorporationUnited StatesMakeri-CAT FLX V-Series · i-CAT FLX V10 · i-CAT FLX V17 · i-CAT FLX V8 · +322026
Fussen Technology Co., LtdChinaMakerDental Computed Tomography X-ray System · Rubik XSmart22026
Planmeca OyFinlandMakerPlanmeca Viso · Planmeca Viso G5 · Planmeca Viso G7252023
De Götzen S.R.L.ItalyMakerX-MIND optima 3D · X-MIND prime 3D · X-MIND trium62023
Hdx Will Corp.South KoreaMakerDental X-ray system · DENTRI Max (DENTRI?, DENTRI-C?, DENTRI-S?) · DENTRI? series (DENTRI?, DENTRI-C?, DENTRI-S?) · DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) · +162021
Trident SRLItalyMakerX-VIEW 3D PAN; X-VIEW 2D PAN52023
Dentium Co.,Ltd(ICT branch)South KoreaMakerbright CT · bright MCT · rainbow CT · rainbow MCT32023
Planmed OyFinlandMakerPlanmed Verity32022
Hefei Meyer Optoelectronic Technology Inc.ChinaMakerDental Cone-beam Computed Tomography (mDX-15P Series)12026
Changzhou Finno Medical Technology Co., Ltd.ChinaMakerDental Cone-beam Computed Tomography (model: FinScan F350)12025
Carestream Dental LLCUnited StatesMakerCEPHALOSTAT · CS 8100 3D · CS 8100 3D Access · CS 8100SC 3D · +9112020
Epica InternationalUnited StatesMakerSEE FACTOR CT3 · SeeFactor CT312019
Icrco, Inc.United StatesMakerClaris CBCT · Claris XT12012
Beyes Dental IncCanadaMakerDURAY 2D, DURAY 2D Ceph, DURAY 3D and DURAY 3D Ceph——
J. Morita MFG Corp.JapanMakerVeraview FX800 Model X800N · Veraview X800——
XLINE S.r.l.ItalyMakerStellaris 2D · Stellaris 2D Ceph · Stellaris 3D · Stellaris 3D Ceph——
CurveBeamUnited StatesMakerPedCAT——
IRAY Imaging LLCUnited StatesMaker———
Turner Medical Inc.United StatesMaker———
Young Innovations IncUnited StatesContract manufacturerPanoramic232025
Changzhou Sifary Medical Technology Co., Ltd.ChinaForeign exporterDental Cone-beam Computed Tomography (model: FinScan F350)42026
Ray America Inc.United StatesListerRAYPreMiere · RAYQUANTUM · RAYSCAN ?-Expert 3D · RAYSCAN a+ · +11——
Owandy Radiology SASFranceRepacker / relabelerI-MAX 3D——
Sanicure BVNetherlandsForeign exporter———
Xtechdental Inc.United StatesListerDental Computed Tomography X-ray System · Matrix7000 · Matrix7800 · Rubik Series CBCT · +4——
LBN Medical ApSDenmarkForeign exporterXW8000 Workstation——
Genoray America Inc.United StatesRepacker / relabelerPAPAYA 3D Plus——
SG Healthcare Co. LtdSouth KoreaRepacker / relabelerHasla——

510(k) clearances

Decided510(k)DeviceApplicant
30 Sep 2026K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)Fussen Technology Co., Ltd
23 Jul 2026K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology Inc.
11 Jun 2026K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.
4 Jun 2026K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.
15 May 2026K253935medXion NEXUSmedXion Technologies, Inc.
9 Apr 2026K260462RCT800Ray Co., Ltd,
31 Mar 2026K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.
10 Mar 2026K252353myray ProXIma X6Cefla S.C.
5 Feb 2026K253959Primevision 3DDentsply Sirona, Inc.
25 Nov 2025K251798RCT700Ray Co., Ltd,
13 Nov 2025K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd
8 Oct 2025K250060GT300; GT300-CGenoray Co., Ltd.
27 Jun 2025K251642Dental CBCT X-ray SystemYian Medical Technology (Haining) Co., Ltd.
17 Apr 2025K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.
12 Mar 2025K243903RCT600Ray Co., Ltd,
21 Feb 2025K243088Green X 12 SE (PHT-40CHS)VATECH Co., Ltd.
14 Feb 2025K243081Green X 21 (PHT-90CHO)VATECH Co., Ltd.
9 Jan 2025K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.
12 Sep 2024K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)PaloDEx Group Oy
6 Sep 2024K233806T2 PlusOsstem Implant Co., Ltd.
25 Apr 2024K240855Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd.
9 Jan 2024K232710Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd.
28 Dec 2023K230985Planmeca VisoPlanmeca Oy
14 Dec 2023K231181bright CTDentium Co.,Ltd(ICT branch)
14 Sep 2023K232487Provecta 3D Prime and Provecta 3D Prime CephDurr Dental SE
8 Sep 2023K232166PreXion3D ExpeditionPrexion Corporation
31 Aug 2023K232287RAYSCAN a-Expert3DRay Co., Ltd,
19 Jul 2023K231796Grreen X 12 (Model: PHT-75CHS)VATECH Co., Ltd.
10 Jul 2023K222666X-View 3D Pan/X-View 2D PanTrident SRL
9 Jun 2023K230505Orthopantomograph™ OP 3D LXPaloDEx Group Oy
11 Apr 2023K230753RCT800Ray Co., Ltd,
7 Apr 2023K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontologica
17 Jan 2023K223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C.
12 Jan 2023K222150PreXion3D ExpeditionPrexion Corporation
6 Dec 2022K222219R2 Studio Q/RCT820Megagen Implant Co., Ltd.
22 Jul 2022K221525PreXion3D Explorer PROPrexion Corporation
19 May 2022K220392PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd.
28 Apr 2022K213278Planmed VerityPlanmed Oy
2 Mar 2022K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L
20 Jan 2022K214084hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C.
30 Dec 2021K211159eco-x Series (eco-x, eco-x-s)Hdx Will Corp.
29 Nov 2021K213226RCT700Ray Co., Ltd,
19 Oct 2021K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp.
21 Sep 2021K212303T2Osstem Implant Co., Ltd.
10 Aug 2021K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontologica
16 Apr 2021K200271rainbow CTDentium Co.,Ltd(ICT branch)
16 Apr 2021K200270rainbow MCTDentium Co.,Ltd(ICT branch)
23 Feb 2021K203784PreXion3D Explorer PROPrexion Corporation
18 Feb 2021K210329Green X 18(Model : PHT-75CHS)VATECH Co., Ltd.
18 Feb 2021K2013783D Accuitomo 150NJ. Morita USA, Inc.
25 Jan 2021K203797vatech A9 (Model : PHT-30CSS)VATECH Co., Ltd.
18 Nov 2020K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Götzen S.R.L.
27 Oct 2020K201627Dental Computed Tomography X-Ray System, Green XVATECH Co., Ltd.
16 Sep 2020K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd.
6 Aug 2020K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation
22 Jun 2020K201140AxeosDentsply Sirona, Inc.
9 Apr 2020K200688hyperion X5, NewTom GO, X-RADiUS COMPACTCefla S.C.
9 Apr 2020K193329PreXion3D Explorer EXPrexion Corporation
13 Mar 2020K200183CS 9600Carestream Dental LLC
5 Mar 2020K193139ProVecta 3D Prime CephDurr Dental SE
22 Oct 2019K192737RCT800Ray Co., Ltd,
20 Sep 2019K190856SeeFactorCT3Epica International
30 Aug 2019K183475T1-CS, T1-COsstem Implant Co., Ltd.
16 Jul 2019K191616Orthophos SDentsply Sirona, Inc.
24 Apr 2019K190812RAYSCAN a-Expert3DRay Co., Ltd,
24 Apr 2019K190496hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C.
15 Apr 2019K190320PreXion3D ExplorerPrexion Corporation
14 Dec 2018K182805RCT800Ray Co., Ltd,
30 Nov 2018K180918Planmed VerityPlanmed Oy
2 Nov 2018K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)Villa Sistemi Medicali S.P.A.
16 Oct 2018K182614RCT700Ray Co., Ltd,
13 Sep 2018K181576Planmeca VisoPlanmeca Oy
17 Aug 2018K181983PreXion 3D ExcelsiorPrexion Corporation
2 Aug 2018K181432ProVectra 3D Prime with VistaSoftDurr Dental SE
27 Jul 2018K181452RCT800Ray Co., Ltd,
7 Jun 2018K180947Orthopantomograph OP 3DPaloDEx Group Oy
24 May 2018K181136CS 9600Carestream Dental LLC
19 Jan 2018K173878PreXion3D ExcelsiorPrexion Corporation
19 Dec 2017K171012Veraview X800J. Morita USA, Inc.
31 Aug 2017K163423Orthopantomograph OP300PaloDEx Group Oy
16 Jun 2017K170066Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd.
7 Apr 2017K170813ORTHOPANTOMOGRAPH OP 3DPaloDEx Group Oy
9 Dec 2016K161900HYPERION X5Cefla S.C.
15 Nov 2016K160166X-MIND triumDe Götzen S.R.L.
10 Nov 2016K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International
28 Oct 2016K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd.
20 Oct 2016K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.
3 Oct 2016K161881PreXion3D ExcelsiorPrexion Corporation
30 Sep 2016K160140DENTRIa seriesHdx Will Corp.
20 Jun 2016K160525RCT700Ray Co., Ltd,
7 Jun 2016K151137X-VIEW, IMAGENEdlen Imaging, LLC
20 May 2016K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy
31 Mar 2016K151612NewTom VGi evoQr S.R.L.
4 Feb 2016K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.
10 Dec 2015K150354PAPAYA 3D PlusGenoray Co., Ltd.
23 Oct 2015K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd.
14 May 2015K143435Planmed VerityPlanmed Oy
8 May 2015K150217ORTHOPHOS SLDentsply Sirona, Inc.
17 Apr 2015K142247RAYSCAN A-EXPERT 3DRay Co., Ltd,
4 Sep 2014K133797QMASTER-H/REVOTelesystems Co., Ltd.
7 Aug 2014K132983TON-95LH, PAX-I3D ORTHOVATECH Co., Ltd.
14 May 2014K133620CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEMImaging Sciences International
26 Mar 2014K133544OP300PaloDEx Group Oy
14 Mar 2014K133406CS 8100 3DCarestream Dental LLC
1 Nov 2013K131695RAYSCAN A-EXPERT 3DRay Co., Ltd,
18 Jul 2013K123332NAOMI-CTLk Consulting Group
3 Jul 2013K130442NEWTOM VGI AND NEWTOM 5GQr S.R.L.
14 Jun 2013K130443I-MAX TOUCH 3DOwandy
31 May 2013K130432PHT-6500, PHT-60CFOVATECH Co., Ltd.
29 May 2013K130297SCANORA 3DXPaloDEx Group Oy
10 May 2013K123381HYPERION X9Cefla S.C.
18 Apr 2013K122199PREXION3D ECLIPSEThe Yoshida Dental Mfg. Co., Ltd.
15 Mar 2013K123070GALILEOS FAMILYDentsply Sirona, Inc.
12 Mar 2013K122981RAYSCAN A-EXPERT 3DRay Co., Ltd,
21 Dec 2012K120948PREXION 3DThe Yoshida Dental Mfg. Co., Ltd.
10 Dec 2012K122018OP300PaloDEx Group Oy
20 Nov 2012K122606PHT-6500; PHT-60CFO; PAX-I3DMtechgroup
28 Aug 2012K121400PAX-UNI3D, PHT-7500VATECH Co., Ltd.
26 Jul 2012K120753CLARISCTIcrco, Inc.
8 Jun 2012K121412PAX-FLEX3D, PHT-7000VATECH Co., Ltd.
24 May 2012K121236PAX-DUO3D PLUS, PCT-5000VATECH Co., Ltd.
18 Aug 2011K103659CS 9300, CS 9300CCarestream Dental LLC
19 Jul 2011K101181BEL-CATTakara Belmont Corporation
30 Jun 2011K110839SCANORA 3DSoredex Palodex Group OY
6 Apr 2011K110260NEWTOM 5G / NEWTOM 5G VERSION FPQr S.R.L.
25 Mar 2011K102196COMPUTED TOMOGRAPHY X-RAY SYSTEMVATECH Co., Ltd.
22 Mar 2011K103711ORTHOPHOS XG 3D / CEPHDentsply Sirona, Inc.
8 Jan 2010K090467DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3DVATECH Co., Ltd.
2 Jun 2009K083917X-RAY, TOMOGRAPHY, COMPUTED, DENTALSuni Medical Imaging, Inc.
30 Apr 2009K090171COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3DE-Woo Technology
31 Oct 2008K082410MASTER3DSE-Woo Technology
10 Oct 2008K082350PAX-500VATECH Co., Ltd.
8 Feb 2007K063622FINECUBE DENTAL CTThe Yoshida Dental Mfg. Co., Ltd.
31 Jan 2007K063773VOLUMETRIC TOMOGRAPHYInstrumentarium Dental, Inc.
14 May 2004K041137NEWTOM 3G QR-DVT 9000Aperio Services, LLC
8 Mar 2001K003787NEWTOM QR-DVT 9000Aperio Services, LLC

Official records: FDA product classification for OAS · 21 CFR 892.1750.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026