FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Straumann Variobase Abutments XC for Bridge/Bar
K Number: K253315
·
Decision Jan 22, 2026
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
90
Review Days
114
Basic Information
- Device Name
- Straumann Variobase Abutments XC for Bridge/Bar
- K Number
- K253315
- 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 30, 2025
- Decision Date
- January 22, 2026
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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