FDA 510(k)
FDA unclassified
Substantially Equivalent
🇰🇷 South Korea
I-ROOT
K Number: K100450
·
Decision Nov 18, 2010
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
4
Review Days
274
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Basic Information
- Device Name
- I-ROOT
- K Number
- K100450
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S-Denti Co., Ltd.
- Date Received
- February 17, 2010
- Decision Date
- November 18, 2010
- Product Code
- LQY
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LQY | Locator, Root Apex | FDA unclassified | Unknown |
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