FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
K Number: K061823
·
Decision Jul 21, 2006
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
119
Review Days
23
Basic Information
- Device Name
- ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
- K Number
- K061823
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Voco GmbH
- Date Received
- June 28, 2006
- Decision Date
- July 21, 2006
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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