Innovative Bioceramix, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231259 | iRoot SP Plus | May 31, 2023 |
| K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Pl | November 22, 2022 |
| K130312 | IROOT FM | September 18, 2014 |
| K102867 | IROOT FS | December 3, 2010 |
| K092715 | IROOT BP PLUS | September 28, 2009 |
| K082943 | IROOT BP, MODEL IRBP 4609 | January 6, 2009 |
| K080917 | IROOT SP | April 9, 2008 |
| K063422 | BIOAGGREGATE | November 21, 2006 |