FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
CORE*IT DUAL
K Number: K092572
·
Decision Aug 26, 2009
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
17
Review Days
5
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Basic Information
- Device Name
- CORE*IT DUAL
- K Number
- K092572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spident Co., Ltd.
- Date Received
- August 21, 2009
- Decision Date
- August 26, 2009
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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