OAS

X-Ray, Tomography, Computed, Dental

Product code
OAS
Device name
X-Ray, Tomography, Computed, Dental
Device class
Class 2
21 CFR
21 CFR 892.1750
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
24
Summaries archived here
22 (direct download)
510(k) clearances (all years, FDA)
135 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (24)

Last three years. Most recent: 2026-07-23.

NumberDecision dateApplicantDevice nameSummary
K2617482026-07-23Hefei Meyer Optoelectronic Technology,…Dental Cone-beam Computed Tomography (mDX-15P Series…PDF
K2508392026-06-11Changzhou Boen Zhongding Medical Techn…Dental X-ray SystemPDF
K2606622026-06-04Yofo Medical Technology Co., Ltd.Dental Cone Beam Computed Tomography SystemPDF
K2539352026-05-15medXion Technologies, Inc.medXion NEXUSPDF
K2604622026-04-09Ray Co., Ltd.RCT800PDF
K2600932026-03-31VATECH Co., Ltd.Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)PDF
K2523532026-03-10Cefla S.C.myray ProXIma X6PDF
K2539592026-02-05Dentsply SironaPrimevision 3DPDF
K2517982025-11-25Ray Co., Ltd.RCT700PDF
K2518422025-11-13Fussen Technology Co., Ltd.Dental Computed Tomography X-ray SystemPDF
K2500602025-10-08Genoray Co., Ltd.GT300; GT300-CPDF
K2516422025-06-27Yian Medical Technology (Haining) Co.,…Dental CBCT X-ray SystemPDF
K2433372025-04-17Yofo Medical Technology Co., Ltd.Dental Cone Beam Computed Tomography SystemPDF
K2439032025-03-12Ray Co., Ltd.RCT600PDF
K2430882025-02-21VATECH Co., Ltd.Green X 12 SE (PHT-40CHS)PDF
K2430812025-02-14VATECH Co., Ltd.Green X 21 (PHT-90CHO)PDF
K2428052025-01-09Changzhou Finno Medical Technology Co.…Dental Cone-beam Computed Tomography (FinScan F350)PDF
K2412492024-09-12Palodex Group OYOrthopantomograph™ OP 3D LX (PAN 3D); Orthopantomogr…PDF
K2338062024-09-06Osstem Implant Co., Ltd.T2 PlusPDF
K2408552024-04-25Yian Medical Technology (Haining) Co.,…Dental Cone-beam Computed TomographyPDF
K2327102024-01-09Yian Medical Technology (Haining) Co.,…Dental Cone-beam Computed TomographyFDA
K2309852023-12-28Planmeca OyPlanmeca VisoPDF
K2311812023-12-14Dentium Co., Ltd (Ict Branch)bright CTFDA
K2324872023-09-14Durr Dental SEProvecta 3D Prime and Provecta 3D Prime CephPDF

22 summaries are archived here for direct download.

Official FDA classification page: OAS
Classification and pathway per current FDA publications. Data from openFDA (CC0).