Company ยท CA
Innovative Bioceramix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2023. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KIF | Resin, Root Canal Filling | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 2023 | K231259 | iRoot SP Plus Innovative Bioceramix, Inc., CA | KIF |
| Nov 22, 2022 | K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Mater Innovative Bioceramix, Inc., CA | KIF |
| Sep 18, 2014 | K130312 | IROOT FM Innovative Bioceramix, Inc., CA | KIF |
| Dec 3, 2010 | K102867 | IROOT FS Innovative Bioceramix, Inc., CA | KIF |
| Sep 28, 2009 | K092715 | IROOT BP PLUS Innovative Bioceramix, Inc., CA | KIF |
| Jan 6, 2009 | K082943 | IROOT BP, MODEL IRBP 4609 Innovative Bioceramix, Inc., CA | KIF |
| Apr 9, 2008 | K080917 | IROOT SP Innovative Bioceramix, Inc., CA | KIF |
| Nov 21, 2006 | K063422 | BIOAGGREGATE Innovative Bioceramix, Inc., CA | KIF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||