FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MTA vpt
K Number: K251390
·
Decision Jul 3, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
119
Review Days
59
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Basic Information
- Device Name
- MTA vpt
- K Number
- K251390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Voco GmbH
- Date Received
- May 5, 2025
- Decision Date
- July 3, 2025
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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