FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
i-Sil
K Number: K161774
·
Decision Sep 30, 2016
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
17
Review Days
94
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Basic Information
- Device Name
- i-Sil
- K Number
- K161774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spident Co., Ltd.
- Date Received
- June 28, 2016
- Decision Date
- September 30, 2016
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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