FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
CAVEX TEMPORARY CEMENT
K Number: K003791
·
Decision Jan 23, 2001
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
26
Review Days
46
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Basic Information
- Device Name
- CAVEX TEMPORARY CEMENT
- K Number
- K003791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cavex Holland BV
- Date Received
- December 8, 2000
- Decision Date
- January 23, 2001
- 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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