FDA 510(k)
FDA class 1
Substantially Equivalent
🇳🇱 Netherlands
PROVISA CEM
K Number: K073539
·
Decision Jan 31, 2008
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
10
Applicant Total
26
Review Days
45
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Basic Information
- Device Name
- PROVISA CEM
- K Number
- K073539
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cavex Holland BV
- Date Received
- December 17, 2007
- Decision Date
- January 31, 2008
- Product Code
- EMB
- 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 |
|---|---|---|---|
| EMB | Zinc Oxide Eugenol | FDA class 1 | Dental |
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