FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUOROCORE 2
K Number: K083326
·
Decision Feb 10, 2009
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
913
Applicant Total
30
Review Days
90
Basic Information
- Device Name
- FLUOROCORE 2
- K Number
- K083326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DENTSPLY INTERNATIONAL, INC.
- Date Received
- November 12, 2008
- Decision Date
- February 10, 2009
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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