Dental X-ray System

FDA 510(k) K250839 · Changzhou Boen Zhongding Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK250839

Submission

Device name
Dental X-ray System
Applicant
Changzhou Boen Zhongding Medical Technology Co., Ltd.
Changzhou, CN
Received
March 20, 2025
Decision date
June 11, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAS – X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

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

Other 510(k)s with product code OAS

510(k)DeviceApplicantDecision
K261748Dental Cone-beam Computed Tomography (mDX-15P Series)OAS · Traditional Hefei Meyer Optoelectronic Technology, Inc.07/23/2026SE
K260662Dental Cone Beam Computed Tomography SystemOAS · Special Yofo Medical Technology Co., Ltd.06/04/2026SE
K253935medXion NEXUSOAS · Traditional medXion Technologies, Inc.05/15/2026SE
K260462RCT800OAS · Special Ray Co., Ltd.04/09/2026SE
K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special VATECH Co., Ltd.03/31/2026SE
K252353myray ProXIma X6OAS · Traditional Cefla S.C.03/10/2026SE
K253959Primevision 3DOAS · Traditional Dentsply Sirona02/05/2026SE
K251798RCT700OAS · Traditional Ray Co., Ltd.11/25/2025SE
K251842Dental Computed Tomography X-ray SystemOAS · Traditional Fussen Technology Co., Ltd.11/13/2025SE
K250060GT300; GT300-COAS · Traditional Genoray Co., Ltd.10/08/2025SE

Questions and answers

When was Dental X-ray System cleared by the FDA?

Dental X-ray System (K250839) received a 510(k) decision of Substantially Equivalent on June 11, 2026, 448 days after the submission was received.

What is the product code of K250839?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.