Product Code: OAS FDA class 2 21 CFR 892.1750

X-Ray, Tomography, Computed, Dental

Radiology

The X-Ray, Tomography, Computed, Dental (product code OAS) is a dental computed tomography (CT) imaging system used to produce cross-sectional diagnostic X-ray images of intraoral tissue and teeth, supporting diagnosis and treatment planning in dentistry and oral surgery. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 892.1750 within the Radiology specialty. The device carries no implant or life-sustaining flags.

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510(k)s

134

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OAS
Device Class: FDA class 2
Regulation Number: 892.1750
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 134 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250839	Dental X-ray System	Jun 11, 2026	Substantially Equivalent	Changzhou Boen Zhongding Medical Technology Co., Ltd.
K260662	Dental Cone Beam Computed Tomography System	Jun 04, 2026	Substantially Equivalent	Yofo Medical Technology Co., Ltd.
K253935	medXion NEXUS	May 15, 2026	Substantially Equivalent	medXion Technologies, Inc.
K260462	RCT800	Apr 09, 2026	Substantially Equivalent	Ray Co., Ltd.
K260093	Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)	Mar 31, 2026	Substantially Equivalent	VATECH Co., Ltd.
K252353	myray ProXIma X6	Mar 10, 2026	Substantially Equivalent	Cefla S.C.
K253959	Primevision 3D	Feb 05, 2026	Substantially Equivalent	Dentsply Sirona
K251798	RCT700	Nov 25, 2025	Substantially Equivalent	Ray Co., Ltd.
K251842	Dental Computed Tomography X-ray System	Nov 13, 2025	Substantially Equivalent	Fussen Technology Co., Ltd.
K250060	GT300; GT300-C	Oct 08, 2025	Substantially Equivalent	Genoray Co., Ltd.
K251642	Dental CBCT X-ray System	Jun 27, 2025	Substantially Equivalent	Yian Medical Technology (Haining) Co., Ltd.
K243337	Dental Cone Beam Computed Tomography System	Apr 17, 2025	Substantially Equivalent	Yofo Medical Technology Co., Ltd.
K243903	RCT600	Mar 12, 2025	Substantially Equivalent	Ray Co., Ltd.
K243088	Green X 12 SE (PHT-40CHS)	Feb 21, 2025	Substantially Equivalent	VATECH Co., Ltd.
K243081	Green X 21 (PHT-90CHO)	Feb 14, 2025	Substantially Equivalent	VATECH Co., Ltd.
K242805	Dental Cone-beam Computed Tomography (FinScan F350)	Jan 09, 2025	Substantially Equivalent	Changzhou Finno Medical Technology Co., Ltd.
K241249	Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)	Sep 12, 2024	Substantially Equivalent	Palodex Group OY
K233806	T2 Plus	Sep 06, 2024	Substantially Equivalent	Osstem Implant Co., Ltd.
K240855	Dental Cone-beam Computed Tomography	Apr 25, 2024	Substantially Equivalent	Yian Medical Technology (Haining) Co., Ltd.
K232710	Dental Cone-beam Computed Tomography	Jan 09, 2024	Substantially Equivalent	Yian Medical Technology (Haining) Co., Ltd.
K230985	Planmeca Viso	Dec 28, 2023	Substantially Equivalent	Planmeca Oy
K231181	bright CT	Dec 14, 2023	Substantially Equivalent	Dentium Co., Ltd (Ict Branch)
K232487	Provecta 3D Prime and Provecta 3D Prime Ceph	Sep 14, 2023	Substantially Equivalent	Durr Dental SE
K232166	PreXion3D Expedition	Sep 08, 2023	Substantially Equivalent	Prexion Corporation
K232287	RAYSCAN a-Expert3D	Aug 31, 2023	Substantially Equivalent	Ray Co., Ltd.
K231796	Grreen X 12 (Model: PHT-75CHS)	Jul 19, 2023	Substantially Equivalent	VATECH Co., Ltd.
K222666	X-View 3D Pan/X-View 2D Pan	Jul 10, 2023	Substantially Equivalent	Trident S.R.L
K230505	Orthopantomograph OP 3D LX	Jun 09, 2023	Substantially Equivalent	Palodex Group OY
K230753	RCT800	Apr 11, 2023	Substantially Equivalent	Ray Co., Ltd.
K223816	Dental CT Scanner AXR	Apr 07, 2023	Substantially Equivalent	Alliage S/A Industrias Medico Odontológica
K223794	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Jan 17, 2023	Substantially Equivalent	Cefla S.C.
K222150	PreXion3D Expedition	Jan 12, 2023	Substantially Equivalent	Prexion Corporation
K222219	R2 Studio Q/RCT820	Dec 06, 2022	Substantially Equivalent	Megagen Implant Co., Ltd.
K221525	PreXion3D Explorer PRO	Jul 22, 2022	Substantially Equivalent	Prexion Corporation
K220392	PAPAYA 3D & PAPAYA 3D Plus	May 19, 2022	Substantially Equivalent	Genoray Co., Ltd.
K213278	Planmed Verity	Apr 28, 2022	Substantially Equivalent	Planmed OY
K213579	Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph	Mar 02, 2022	Substantially Equivalent	Fona S.R.L
K214084	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Jan 20, 2022	Substantially Equivalent	Cefla S.C.
K211159	eco-x Series (eco-x, eco-x-s)	Dec 30, 2021	Substantially Equivalent	Hdx Will Corp.
K213226	RCT700	Nov 29, 2021	Substantially Equivalent	Ray Co., Ltd.
K212254	DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)	Oct 19, 2021	Substantially Equivalent	Hdx Will Corp.
K212303	T2	Sep 21, 2021	Substantially Equivalent	Osstem Implant Co., Ltd.
K210820	EAGLE EDGE AXR90 and AXR120	Aug 10, 2021	Substantially Equivalent	Alliage S/A Industrias Medico Odontológica
K200271	rainbow CT	Apr 16, 2021	Substantially Equivalent	Dentium Co., Ltd (Ict Branch)
K200270	rainbow MCT	Apr 16, 2021	Substantially Equivalent	Dentium Co., Ltd (Ict Branch)
K203784	PreXion3D Explorer PRO	Feb 23, 2021	Substantially Equivalent	Prexion Corporation
K210329	Green X 18(Model : PHT-75CHS)	Feb 18, 2021	Substantially Equivalent	VATECH Co., Ltd.
K201378	3D Accuitomo 150N	Feb 18, 2021	Substantially Equivalent	J. Morita USA, Inc.
K203797	vatech A9 (Model : PHT-30CSS)	Jan 25, 2021	Substantially Equivalent	VATECH Co., Ltd.
K201382	X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)	Nov 18, 2020	Substantially Equivalent	De Gotzen S.R.L.
K201627	Dental Computed Tomography X-Ray System, Green X	Oct 27, 2020	Substantially Equivalent	VATECH Co., Ltd.
K200469	PAPAYA 3D Premium & PAPAYA 3D Premium Plus	Sep 16, 2020	Substantially Equivalent	Genoray Co., Ltd.
K201667	Midmark Extraoral Imaging System (EOIS)	Aug 06, 2020	Substantially Equivalent	Midmark Corporation
K201140	Axeos	Jun 22, 2020	Substantially Equivalent	Dentsply Sirona
K200688	hyperion X5, NewTom GO, X-RADiUS COMPACT	Apr 09, 2020	Substantially Equivalent	Cefla S.C.
K193329	PreXion3D Explorer EX	Apr 09, 2020	Substantially Equivalent	Prexion Corporation
K200183	CS 9600	Mar 13, 2020	Substantially Equivalent	Trophy
K193139	ProVecta 3D Prime Ceph	Mar 05, 2020	Substantially Equivalent	Durr Dental SE
K192737	RCT800	Oct 22, 2019	Substantially Equivalent	Ray Co., Ltd.
K190856	SeeFactorCT3	Sep 20, 2019	Substantially Equivalent	Epica International, Inc.
K183475	T1-CS, T1-C	Aug 30, 2019	Substantially Equivalent	Osstem Implant Co., Ltd.
K191616	Orthophos S	Jul 16, 2019	Substantially Equivalent	Dentsply Sirona
K190812	RAYSCAN a-Expert3D	Apr 24, 2019	Substantially Equivalent	Ray Co., Ltd.
K190496	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Apr 24, 2019	Substantially Equivalent	Cefla S.C.
K190320	PreXion3D Explorer	Apr 15, 2019	Substantially Equivalent	Prexion Corporation
K182805	RCT800	Dec 14, 2018	Substantially Equivalent	Ray Co., Ltd.
K180918	Planmed Verity	Nov 30, 2018	Substantially Equivalent	Planmed OY
K180601	Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)	Nov 02, 2018	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K182614	RCT700	Oct 16, 2018	Substantially Equivalent	Ray Co., Ltd.
K181576	Planmeca Viso	Sep 13, 2018	Substantially Equivalent	Planmeca Oy
K181983	PreXion 3D Excelsior	Aug 17, 2018	Substantially Equivalent	Prexion Corporation
K181432	ProVectra 3D Prime with VistaSoft	Aug 02, 2018	Substantially Equivalent	Durr Dental SE
K181452	RCT800	Jul 27, 2018	Substantially Equivalent	Ray Co., Ltd.
K180947	Orthopantomograph OP 3D	Jun 07, 2018	Substantially Equivalent	Palodex Group OY
K181136	CS 9600	May 24, 2018	Substantially Equivalent	Trophy
K173878	PreXion3D Excelsior	Jan 19, 2018	Substantially Equivalent	Prexion Corporation
K171012	Veraview X800	Dec 19, 2017	Substantially Equivalent	J. Morita USA, Inc.
K163423	Orthopantomograph OP300	Aug 31, 2017	Substantially Equivalent	Palodex Group OY
K170066	Green16/Green18 (Model: PHT-65LHS)	Jun 16, 2017	Substantially Equivalent	VATECH Co., Ltd.
K170813	ORTHOPANTOMOGRAPH OP 3D	Apr 07, 2017	Substantially Equivalent	Palodex Group OY
K161900	HYPERION X5	Dec 09, 2016	Substantially Equivalent	Cefla S.C.
K160166	X-MIND trium	Nov 15, 2016	Substantially Equivalent	De Gotzen S.R.L.
K162085	i-CAT FLX V series / KaVo 3D eXam+ V series	Nov 10, 2016	Substantially Equivalent	Imaging Sciences International
K160882	PaX-i3D Green Premium (Model: PCT-90LH)	Oct 28, 2016	Substantially Equivalent	VATECH Co., Ltd.
K162660	Green Smart (Model: PHT-35LHS)	Oct 20, 2016	Substantially Equivalent	VATECH Co., Ltd.
K161881	PreXion3D Excelsior	Oct 03, 2016	Substantially Equivalent	Prexion Corporation
K160140	DENTRIa series	Sep 30, 2016	Substantially Equivalent	Hdx Will Corp.
K160525	RCT700	Jun 20, 2016	Substantially Equivalent	Ray Co., Ltd.
K151137	X-VIEW, IMAGEN	Jun 07, 2016	Substantially Equivalent	Edlen Imaging, LLC
K160506	Planmeca ProMax 3D Max, Planmeca Maximity	May 20, 2016	Substantially Equivalent	Planmeca Oy
K151612	NewTom VGi evo	Mar 31, 2016	Substantially Equivalent	Qr S.R.L.
K152489	ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray	Feb 04, 2016	Substantially Equivalent	Panoramic Corp.
K150354	PAPAYA 3D Plus	Dec 10, 2015	Substantially Equivalent	Genoray Co., Ltd.
K152106	Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart	Oct 23, 2015	Substantially Equivalent	VATECH Co., Ltd.
K143435	Planmed Verity	May 14, 2015	Substantially Equivalent	Planmed OY
K150217	ORTHOPHOS SL	May 08, 2015	Substantially Equivalent	Sirona Dental Systems GmbH
K142247	RAYSCAN A-EXPERT 3D	Apr 17, 2015	Substantially Equivalent	Ray Co., Ltd.
K133797	QMASTER-H/REVO	Sep 04, 2014	Substantially Equivalent	Telesystems Co., Ltd.
K132983	TON-95LH, PAX-I3D ORTHO	Aug 07, 2014	Substantially Equivalent	VATECH Co., Ltd.
K133620	CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM	May 14, 2014	Substantially Equivalent	Imaging Sciences International
K133544	OP300	Mar 26, 2014	Substantially Equivalent	Palodex Group OY
K133406	CS 8100 3D	Mar 14, 2014	Substantially Equivalent	Trophy
K131695	RAYSCAN A-EXPERT 3D	Nov 01, 2013	Substantially Equivalent	Ray Co., Ltd.
K123332	NAOMI-CT	Jul 18, 2013	Substantially Equivalent	Lk Consulting Group
K130442	NEWTOM VGI AND NEWTOM 5G	Jul 03, 2013	Substantially Equivalent	Qr S.R.L.
K130443	I-MAX TOUCH 3D	Jun 14, 2013	Substantially Equivalent	Owandy
K130432	PHT-6500, PHT-60CFO	May 31, 2013	Substantially Equivalent	VATECH Co., Ltd.
K130297	SCANORA 3DX	May 29, 2013	Substantially Equivalent	Palodex Group OY
K123381	HYPERION X9	May 10, 2013	Substantially Equivalent	Cefla S.C.
K122199	PREXION3D ECLIPSE	Apr 18, 2013	Substantially Equivalent	The Yoshida Dental Mfg. Co., Ltd.
K123070	GALILEOS FAMILY	Mar 15, 2013	Substantially Equivalent	Sirona Dental Systems GmbH
K122981	RAYSCAN A-EXPERT 3D	Mar 12, 2013	Substantially Equivalent	Ray Co., Ltd.
K120948	PREXION 3D	Dec 21, 2012	Substantially Equivalent	The Yoshida Dental Mfg. Co., Ltd.
K122018	OP300	Dec 10, 2012	Substantially Equivalent	Palodex Group OY
K122606	PHT-6500; PHT-60CFO; PAX-I3D	Nov 20, 2012	Substantially Equivalent	Mtechgroup
K121400	PAX-UNI3D, PHT-7500	Aug 28, 2012	Substantially Equivalent	VATECH Co., Ltd.
K120753	CLARISCT	Jul 26, 2012	Substantially Equivalent	Icrco, Inc.
K121412	PAX-FLEX3D, PHT-7000	Jun 08, 2012	Substantially Equivalent	VATECH Co., Ltd.
K121236	PAX-DUO3D PLUS, PCT-5000	May 24, 2012	Substantially Equivalent	VATECH Co., Ltd.
K103659	CS 9300, CS 9300C	Aug 18, 2011	Substantially Equivalent	Trophy
K101181	BEL-CAT	Jul 19, 2011	Substantially Equivalent	Takara Belmont Corp.
K110839	SCANORA 3D	Jun 30, 2011	Substantially Equivalent	Soredex Palodex Group OY
K110260	NEWTOM 5G / NEWTOM 5G VERSION FP	Apr 06, 2011	Substantially Equivalent	Qr S.R.L.
K102196	COMPUTED TOMOGRAPHY X-RAY SYSTEM	Mar 25, 2011	Substantially Equivalent	VATECH Co., Ltd.
K103711	ORTHOPHOS XG 3D / CEPH	Mar 22, 2011	Substantially Equivalent	Sirona Dental Systems GmbH
K090467	DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D	Jan 08, 2010	Substantially Equivalent	VATECH Co., Ltd.
K083917	X-RAY, TOMOGRAPHY, COMPUTED, DENTAL	Jun 02, 2009	Substantially Equivalent	Suni Medical Imaging, Inc.
K090171	COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D	Apr 30, 2009	Substantially Equivalent	E-Woo Technology
K082410	MASTER3DS	Oct 31, 2008	Substantially Equivalent	E-Woo Technology
K082350	PAX-500	Oct 10, 2008	Substantially Equivalent	VATECH Co., Ltd.
K063622	FINECUBE DENTAL CT	Feb 08, 2007	Substantially Equivalent	The Yoshida Dental Mfg. Co., Ltd.
K063773	VOLUMETRIC TOMOGRAPHY	Jan 31, 2007	Substantially Equivalent	Instrumentarium Dental, Inc.
K041137	NEWTOM 3G QR-DVT 9000	May 14, 2004	Substantially Equivalent	Aperio Services, LLC
K003787	NEWTOM QR-DVT 9000	Mar 08, 2001	Substantially Equivalent	Aperio Services, LLC