FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CEREC OPTI SPRAY
K Number: K080882
·
Decision Apr 11, 2008
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
42
Review Days
11
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Basic Information
- Device Name
- CEREC OPTI SPRAY
- K Number
- K080882
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sirona Dental Systems GmbH
- Date Received
- March 31, 2008
- Decision Date
- April 11, 2008
- Product Code
- ELW
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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