FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Dental X-ray System
K Number: K250839
·
Decision Jun 11, 2026
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
1
Review Days
448
Basic Information
- Device Name
- Dental X-ray System
- K Number
- K250839
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Changzhou Boen Zhongding Medical Technology Co., Ltd.
- Date Received
- March 20, 2025
- Decision Date
- June 11, 2026
- Product Code
- OAS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAS), ordered by most recent decision date.
Dental Cone Beam Computed Tomography System
FDA 510(k)
FDA Class 2
·Radiology
medXion NEXUS
FDA 510(k)
FDA Class 2
·Radiology
RCT800
FDA 510(k)
FDA Class 2
·Radiology
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
FDA 510(k)
FDA Class 2
·Radiology
myray ProXIma X6
FDA 510(k)
FDA Class 2
·Radiology
Primevision 3D
FDA 510(k)
FDA Class 2
·Radiology