FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VSP System
K Number: K192192
·
Decision Feb 26, 2020
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
31
Applicant Total
5
Review Days
197
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Basic Information
- Device Name
- VSP System
- K Number
- K192192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D Systems
- Date Received
- August 13, 2019
- Decision Date
- February 26, 2020
- Product Code
- DZJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZJ | Driver, Wire, And Bone Drill, Manual | FDA class 2 | Dental |
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