FDA 510(k)
FDA unclassified
Substantially Equivalent
🇩🇪 Germany
VOCO Retraction Paste
K Number: K213149
·
Decision Dec 9, 2021
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
35
Applicant Total
119
Review Days
73
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Basic Information
- Device Name
- VOCO Retraction Paste
- K Number
- K213149
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Voco GmbH
- Date Received
- September 27, 2021
- Decision Date
- December 9, 2021
- Product Code
- MVL
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MVL | Cord, Retraction | FDA unclassified | Unknown |
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