FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Straumann CARES Visual and Nova Dental CAD
K Number: K233252
·
Decision Dec 26, 2024
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
7
Applicant Total
49
Review Days
455
Basic Information
- Device Name
- Straumann CARES Visual and Nova Dental CAD
- K Number
- K233252
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Institut Straumann AG
- Date Received
- September 28, 2023
- Decision Date
- December 26, 2024
- Product Code
- PNP
- 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 |
|---|---|---|---|
| PNP | Dental Abutment Design Software For Dental Laboratory | FDA class 2 | Dental |
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