OAS · X-Ray, Tomography, Computed, Dental

Device class

Class II

Regulation 892.1750

Total clearances

2020-03-05 → 2026-07-23

Last 12 months

Unique sponsors

Definition

What is X-Ray, Tomography, Computed, Dental

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

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.1750

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
VATECH Co., Ltd.	7	1	2026-03-31
Ray Co., Ltd.	6	2	2026-04-09
Prexion Corporation	5	0	2023-09-08
Cefla S.C.	4	1	2026-03-10
Yian Medical Technology (Haining) Co., Ltd.	3	0	2025-06-27
Dentium Co., Ltd (Ict Branch)	3	0	2023-12-14
Genoray Co., Ltd.	3	1	2025-10-08
Yofo Medical Technology Co., Ltd.	2	1	2026-06-04
Palodex Group OY	2	0	2024-09-12
Dentsply Sirona	2	1	2026-02-05
Durr Dental SE	2	0	2023-09-14
Alliage S/A Industrias Medico Odontológica	2	0	2023-04-07
Hdx Will Corp.	2	0	2021-12-30
Osstem Implant Co., Ltd.	2	0	2024-09-06
J. Morita USA, Inc.	1	0	2021-02-18
Planmeca Oy	1	0	2023-12-28
medXion Technologies, Inc.	1	1	2026-05-15
Midmark Corporation	1	0	2020-08-06
Fona S.R.L	1	0	2022-03-02
Trident S.R.L	1	0	2023-07-10
Fussen Technology Co., Ltd.	1	1	2025-11-13
Changzhou Finno Medical Technology Co., Ltd.	1	0	2025-01-09
De Gotzen S.R.L.	1	0	2020-11-18
Planmed OY	1	0	2022-04-28
Trophy	1	0	2020-03-13

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
76377	CPT	—	High	3D rendering with interpretation of CT images; dental CT tomography standard code
70553	CPT	—	Medium	Imaging head/neck with CT; may apply for dental CT depending on scope

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-23	K261748	Hefei Meyer Optoelectronic Technology, Inc.	Dental Cone-beam Computed Tomography (mDX-15P Series)
2026-06-11	K250839	Changzhou Boen Zhongding Medical Technology Co., Ltd.	Dental X-ray System
2026-06-04	K260662	Yofo Medical Technology Co., Ltd.	Dental Cone Beam Computed Tomography System
2026-05-15	K253935	medXion Technologies, Inc.	medXion NEXUS
2026-04-09	K260462	Ray Co., Ltd.	RCT800
2026-03-31	K260093	VATECH Co., Ltd.	Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
2026-03-10	K252353	Cefla S.C.	myray ProXIma X6
2026-02-05	K253959	Dentsply Sirona	Primevision 3D
2025-11-25	K251798	Ray Co., Ltd.	RCT700
2025-11-13	K251842	Fussen Technology Co., Ltd.	Dental Computed Tomography X-ray System
2025-10-08	K250060	Genoray Co., Ltd.	GT300; GT300-C
2025-06-27	K251642	Yian Medical Technology (Haining) Co., Ltd.	Dental CBCT X-ray System
2025-04-17	K243337	Yofo Medical Technology Co., Ltd.	Dental Cone Beam Computed Tomography System
2025-03-12	K243903	Ray Co., Ltd.	RCT600
2025-02-21	K243088	VATECH Co., Ltd.	Green X 12 SE (PHT-40CHS)
2025-02-14	K243081	VATECH Co., Ltd.	Green X 21 (PHT-90CHO)
2025-01-09	K242805	Changzhou Finno Medical Technology Co., Ltd.	Dental Cone-beam Computed Tomography (FinScan F350)
2024-09-12	K241249	Palodex Group OY	Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)
2024-09-06	K233806	Osstem Implant Co., Ltd.	T2 Plus
2024-04-25	K240855	Yian Medical Technology (Haining) Co., Ltd.	Dental Cone-beam Computed Tomography
2024-01-09	K232710	Yian Medical Technology (Haining) Co., Ltd.	Dental Cone-beam Computed Tomography
2023-12-28	K230985	Planmeca Oy	Planmeca Viso
2023-12-14	K231181	Dentium Co., Ltd (Ict Branch)	bright CT
2023-09-14	K232487	Durr Dental SE	Provecta 3D Prime and Provecta 3D Prime Ceph
2023-09-08	K232166	Prexion Corporation	PreXion3D Expedition