FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
VarioSurg 4
K Number: K254163
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
40
Review Days
1
Basic Information
- Device Name
- VarioSurg 4
- K Number
- K254163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nakanishi, Inc.
- Date Received
- December 22, 2025
- Decision Date
- December 23, 2025
- Product Code
- DZI
- 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 |
|---|---|---|---|
| DZI | Drill, Bone, Powered | FDA class 2 | Dental |
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