FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ECO-S
K Number: K103121
·
Decision Oct 26, 2010
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
20
Review Days
4
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Basic Information
- Device Name
- ECO-S
- K Number
- K103121
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vericom Co., Ltd.
- Date Received
- October 22, 2010
- Decision Date
- October 26, 2010
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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