FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MERON APPLICATION CAPSULES
K Number: K130421
·
Decision Aug 14, 2013
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
495
Applicant Total
94
Review Days
175
Basic Information
- Device Name
- MERON APPLICATION CAPSULES
- K Number
- K130421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- VOCO GMBH
- Date Received
- February 20, 2013
- Decision Date
- August 14, 2013
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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