FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
IROOT 100 MINI
K Number: K112153
·
Decision Apr 26, 2012
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
4
Review Days
294
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Basic Information
- Device Name
- IROOT 100 MINI
- K Number
- K112153
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S-Denti Co., Ltd.
- Date Received
- July 7, 2011
- Decision Date
- April 26, 2012
- 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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