FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Portable Dental X-ray Device (GT-1)
K Number: K254018
·
Decision Feb 19, 2026
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
3
Review Days
66
Basic Information
- Device Name
- Portable Dental X-ray Device (GT-1)
- K Number
- K254018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guilin Refine Medical Instrument Co., Ltd.
- Date Received
- December 15, 2025
- Decision Date
- February 19, 2026
- Product Code
- EHD
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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