FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
IROOT FM
K Number: K130312
·
Decision Sep 18, 2014
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
8
Review Days
588
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Basic Information
- Device Name
- IROOT FM
- K Number
- K130312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Bioceramix, Inc.
- Date Received
- February 7, 2013
- Decision Date
- September 18, 2014
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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Other Clearances by Innovative Bioceramix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231259 | iRoot SP Plus | May 31, 2023 | Substantially Equivalent |
| K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | Nov 22, 2022 | Substantially Equivalent |
| K102867 | IROOT FS | Dec 3, 2010 | Substantially Equivalent |
| K092715 | IROOT BP PLUS | Sep 28, 2009 | Substantially Equivalent |
| K082943 | IROOT BP, MODEL IRBP 4609 | Jan 6, 2009 | Substantially Equivalent |
| K080917 | IROOT SP | Apr 9, 2008 | Substantially Equivalent |
| K063422 | BIOAGGREGATE | Nov 21, 2006 | Substantially Equivalent |