OAS — X-Ray, Tomography, Computed, Dental Class II

FDA Device Classification

Classification Details

Product Code
OAS
Device Class
Class II
Regulation Number
892.1750
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252353cefla s.cmyray ProXIma X6March 10, 2026
K253959dentsply sironaPrimevision 3DFebruary 5, 2026
K251798ray coRCT700November 25, 2025
K251842fussen technology coDental Computed Tomography X-ray SystemNovember 13, 2025
K250060genoray coGT300; GT300-COctober 8, 2025
K251642yian medical technology (haining) coDental CBCT X-ray SystemJune 27, 2025
K243337yofo medical technology coDental Cone Beam Computed Tomography SystemApril 17, 2025
K243903ray coRCT600March 12, 2025
K243088vatech coGreen X 12 SE (PHT-40CHS)February 21, 2025
K243081vatech coGreen X 21 (PHT-90CHO)February 14, 2025
K242805changzhou finno medical technology coDental Cone-beam Computed Tomography (FinScan F350)January 9, 2025
K241249palodex groupOrthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)September 12, 2024
K233806osstem implant coT2 PlusSeptember 6, 2024
K240855yian medical technology (haining) coDental Cone-beam Computed TomographyApril 25, 2024
K232710yian medical technology (haining) coDental Cone-beam Computed TomographyJanuary 9, 2024
K230985planmecaPlanmeca VisoDecember 28, 2023
K231181dentium co., ltd (ict branch)bright CTDecember 14, 2023
K232487durr dental seProvecta 3D Prime and Provecta 3D Prime CephSeptember 14, 2023
K232166prexion corporationPreXion3D ExpeditionSeptember 8, 2023
K232287ray coRAYSCAN a-Expert3DAugust 31, 2023