X-Ray, Tomography, Computed, Dental

FDA product code OAS · 125 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1750
Review panel: RA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2001-03-08 – 2026-07-23

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

OAS 2026-07-23

Dental Cone-beam Computed Tomography (mDX-15P Series)

Applicant Hefei Meyer Optoelectronic Technology, Inc.

K number K261748

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OAS 2026-06-11

Dental X-ray System

Applicant Changzhou Boen Zhongding Medical Technology Co., Ltd.

K number K250839

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OAS 2026-06-04

Dental Cone Beam Computed Tomography System

Applicant Yofo Medical Technology Co., Ltd.

K number K260662

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OAS 2026-05-15

medXion NEXUS

Applicant medXion Technologies, Inc.

K number K253935

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OAS 2026-04-09

RCT800

Applicant Ray Co., Ltd.

K number K260462

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OAS 2026-03-31

Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)

Applicant VATECH Co., Ltd.

K number K260093

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OAS 2026-03-10

myray ProXIma X6

Applicant Cefla S.C.

K number K252353

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OAS 2026-02-05

Primevision 3D

Applicant Dentsply Sirona

K number K253959

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OAS 2025-11-25

RCT700

Applicant Ray Co., Ltd.

K number K251798

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OAS 2025-11-13

Dental Computed Tomography X-ray System

Applicant Fussen Technology Co., Ltd.

K number K251842

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OAS 2025-10-08

GT300; GT300-C

Applicant Genoray Co., Ltd.

K number K250060

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OAS 2025-06-27

Dental CBCT X-ray System

Applicant Yian Medical Technology (Haining) Co., Ltd.

K number K251642

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OAS 2025-04-17

Dental Cone Beam Computed Tomography System

Applicant Yofo Medical Technology Co., Ltd.

K number K243337

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OAS 2025-03-12

RCT600

Applicant Ray Co., Ltd.

K number K243903

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OAS 2025-02-21

Green X 12 SE (PHT-40CHS)

Applicant VATECH Co., Ltd.

K number K243088

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OAS 2025-02-14

Green X 21 (PHT-90CHO)

Applicant VATECH Co., Ltd.

K number K243081

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OAS 2025-01-09

Dental Cone-beam Computed Tomography (FinScan F350)

Applicant Changzhou Finno Medical Technology Co., Ltd.

K number K242805

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OAS 2024-09-12

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)

Applicant Palodex Group OY

K number K241249

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OAS 2024-09-06

T2 Plus

Applicant Osstem Implant Co., Ltd.

K number K233806

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OAS 2024-04-25

Dental Cone-beam Computed Tomography

Applicant Yian Medical Technology (Haining) Co., Ltd.

K number K240855

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OAS 2024-01-09

Dental Cone-beam Computed Tomography

Applicant Yian Medical Technology (Haining) Co., Ltd.

K number K232710

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OAS 2023-12-28

Planmeca Viso

Applicant Planmeca Oy

K number K230985

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OAS 2023-12-14

bright CT

Applicant Dentium Co., Ltd (Ict Branch)

K number K231181

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OAS 2023-09-14

Provecta 3D Prime and Provecta 3D Prime Ceph

Applicant Durr Dental SE

K number K232487

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OAS 2023-09-08

PreXion3D Expedition

Applicant Prexion Corporation

K number K232166

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OAS 2023-08-31

RAYSCAN a-Expert3D

Applicant Ray Co., Ltd.

K number K232287

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OAS 2023-07-19

Grreen X 12 (Model: PHT-75CHS)

Applicant VATECH Co., Ltd.

K number K231796

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OAS 2023-07-10

X-View 3D Pan/X-View 2D Pan

Applicant Trident S.R.L

K number K222666

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OAS 2023-06-09

Orthopantomograph™ OP 3D LX

Applicant Palodex Group OY

K number K230505

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OAS 2023-04-11

RCT800

Applicant Ray Co., Ltd.

K number K230753

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OAS 2023-04-07

Dental CT Scanner AXR

Applicant Alliage S/A Industrias Medico Odontológica

K number K223816

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OAS 2023-01-17

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Applicant Cefla S.C.

K number K223794

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OAS 2023-01-12

PreXion3D Expedition

Applicant Prexion Corporation

K number K222150

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OAS 2022-12-06

R2 Studio Q/RCT820

Applicant Megagen Implant Co., Ltd.

K number K222219

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OAS 2022-07-22

PreXion3D Explorer PRO

Applicant Prexion Corporation

K number K221525

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OAS 2022-05-19

PAPAYA 3D & PAPAYA 3D Plus

Applicant Genoray Co., Ltd.

K number K220392

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OAS 2022-04-28

Planmed Verity

Applicant Planmed OY

K number K213278

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OAS 2022-03-02

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

Applicant Fona S.R.L

K number K213579

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OAS 2022-01-20

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Applicant Cefla S.C.

K number K214084

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OAS 2021-12-30

eco-x Series (eco-x, eco-x-s)

Applicant Hdx Will Corp.

K number K211159

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OAS 2021-11-29

RCT700

Applicant Ray Co., Ltd.

K number K213226

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OAS 2021-10-19

DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)

Applicant Hdx Will Corp.

K number K212254

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OAS 2021-09-21

T2

Applicant Osstem Implant Co., Ltd.

K number K212303

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OAS 2021-08-10

EAGLE EDGE AXR90 and AXR120

Applicant Alliage S/A Industrias Medico Odontológica

K number K210820

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OAS 2021-04-16

rainbow CT

Applicant Dentium Co., Ltd (Ict Branch)

K number K200271

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OAS 2021-04-16

rainbow MCT

Applicant Dentium Co., Ltd (Ict Branch)

K number K200270

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OAS 2021-02-23

PreXion3D Explorer PRO

Applicant Prexion Corporation

K number K203784

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OAS 2021-02-18

Green X 18(Model : PHT-75CHS)

Applicant VATECH Co., Ltd.

K number K210329

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OAS 2021-02-18

3D Accuitomo 150N

Applicant J. Morita USA, Inc.

K number K201378

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OAS 2021-01-25

vatech A9 (Model : PHT-30CSS)

Applicant VATECH Co., Ltd.

K number K203797

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OAS 2020-11-18

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

Applicant De Gotzen S.R.L.

K number K201382

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OAS 2020-10-27

Dental Computed Tomography X-Ray System, Green X

Applicant VATECH Co., Ltd.

K number K201627

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OAS 2020-09-16

PAPAYA 3D Premium & PAPAYA 3D Premium Plus

Applicant Genoray Co., Ltd.

K number K200469

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OAS 2020-08-06

Midmark Extraoral Imaging System (EOIS)

Applicant Midmark Corporation

K number K201667

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OAS 2020-06-22

Axeos

Applicant Dentsply Sirona

K number K201140

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OAS 2020-04-09

hyperion X5, NewTom GO, X-RADiUS COMPACT

Applicant Cefla S.C.

K number K200688

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OAS 2020-04-09

PreXion3D Explorer EX

Applicant Prexion Corporation

K number K193329

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OAS 2020-03-13

CS 9600

Applicant Trophy

K number K200183

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OAS 2020-03-05

ProVecta 3D Prime Ceph

Applicant Durr Dental SE

K number K193139

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OAS 2019-10-22

RCT800

Applicant Ray Co., Ltd.

K number K192737

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OAS 2019-09-20

SeeFactorCT3

Applicant Epica International, Inc.

K number K190856

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OAS 2019-08-30

T1-CS, T1-C

Applicant Osstem Implant Co., Ltd.

K number K183475

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OAS 2019-07-16

Orthophos S

Applicant Dentsply Sirona

K number K191616

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OAS 2019-04-24

RAYSCAN a-Expert3D

Applicant Ray Co., Ltd.

K number K190812

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OAS 2019-04-24

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Applicant Cefla S.C.

K number K190496

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OAS 2019-04-15

PreXion3D Explorer

Applicant Prexion Corporation

K number K190320

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OAS 2018-12-14

RCT800

Applicant Ray Co., Ltd.

K number K182805

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OAS 2018-11-30

Planmed Verity

Applicant Planmed OY

K number K180918

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OAS 2018-11-02

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

Applicant Villa Sistemi Medicali S.P.A.

K number K180601

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OAS 2018-10-16

RCT700

Applicant Ray Co., Ltd.

K number K182614

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OAS 2018-09-13

Planmeca Viso

Applicant Planmeca Oy

K number K181576

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OAS 2018-08-17

PreXion 3D Excelsior

Applicant Prexion Corporation

K number K181983

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OAS 2018-08-02

ProVectra 3D Prime with VistaSoft

Applicant Durr Dental SE

K number K181432

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OAS 2018-07-27

RCT800

Applicant Ray Co., Ltd.

K number K181452

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OAS 2018-06-07

Orthopantomograph OP 3D

Applicant Palodex Group OY

K number K180947

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OAS 2018-05-24

CS 9600

Applicant Trophy

K number K181136

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OAS 2018-01-19

PreXion3D Excelsior

Applicant Prexion Corporation

K number K173878

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OAS 2017-12-19

Veraview X800

Applicant J. Morita USA, Inc.

K number K171012

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OAS 2017-08-31

Orthopantomograph OP300

Applicant Palodex Group OY

K number K163423

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OAS 2017-06-16

Green16/Green18 (Model: PHT-65LHS)

Applicant VATECH Co., Ltd.

K number K170066

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OAS 2017-04-07

ORTHOPANTOMOGRAPH OP 3D

Applicant Palodex Group OY

K number K170813

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OAS 2016-12-09

HYPERION X5

Applicant Cefla S.C.

K number K161900

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OAS 2016-11-15

X-MIND trium

Applicant De Gotzen S.R.L.

K number K160166

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OAS 2016-11-10

i-CAT FLX V series / KaVo 3D eXam+ V series

Applicant Imaging Sciences International

K number K162085

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OAS 2016-10-28

PaX-i3D Green Premium (Model: PCT-90LH)

Applicant VATECH Co., Ltd.

K number K160882

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OAS 2016-10-20

Green Smart (Model: PHT-35LHS)

Applicant VATECH Co., Ltd.

K number K162660

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OAS 2016-10-03

PreXion3D Excelsior

Applicant Prexion Corporation

K number K161881

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OAS 2016-09-30

DENTRIa series

Applicant Hdx Will Corp.

K number K160140

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OAS 2016-06-20

RCT700

Applicant Ray Co., Ltd.

K number K160525

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OAS 2016-06-07

X-VIEW, IMAGEN

Applicant Edlen Imaging, LLC

K number K151137

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OAS 2016-05-20

Planmeca ProMax 3D Max, Planmeca Maximity

Applicant Planmeca Oy

K number K160506

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OAS 2016-03-31

NewTom VGi evo

Applicant Qr S.R.L.

K number K151612

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OAS 2016-02-04

ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray

Applicant Panoramic Corp.

K number K152489

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OAS 2013-11-01

RAYSCAN A-EXPERT 3D

Applicant Ray Co., Ltd.

K number K131695

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OAS 2013-07-18

NAOMI-CT

Applicant Lk Consulting Group

K number K123332

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OAS 2013-07-03

NEWTOM VGI AND NEWTOM 5G

Applicant Qr S.R.L.

K number K130442

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OAS 2013-06-14

I-MAX TOUCH 3D

Applicant Owandy

K number K130443

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OAS 2013-05-31

PHT-6500, PHT-60CFO

Applicant VATECH Co., Ltd.

K number K130432

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OAS 2013-05-29

SCANORA 3DX

Applicant Palodex Group OY

K number K130297

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OAS 2013-05-10

HYPERION X9

Applicant Cefla S.C.

K number K123381

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