FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
K Number: K253053
·
Decision Sep 23, 2025
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
5
Review Days
1
Basic Information
- Device Name
- Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
- K Number
- K253053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hangzhou SHINING3D Dental Technology Co., Ltd.
- Date Received
- September 22, 2025
- Decision Date
- September 23, 2025
- Product Code
- EBF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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