Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Innovative Bioceramix with 8 510(k) clearances. The most recent is a 510(k) clearance dated May 31, 2023: iRoot SP Plus.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 31, 2023 | iRoot SP PlusK231259 · KIF | 510(k) clearances |
| Nov 22, 2022 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair MaterialK222992 · KIF | 510(k) clearances |
| Sep 18, 2014 | IROOT FMK130312 · KIF | 510(k) clearances |
| Dec 3, 2010 | IROOT FSK102867 · KIF | 510(k) clearances |
| Sep 28, 2009 | IROOT BP PLUSK092715 · KIF | 510(k) clearances |
| Jan 6, 2009 | IROOT BP, MODEL IRBP 4609K082943 · KIF | 510(k) clearances |
| Apr 9, 2008 | IROOT SPK080917 · KIF | 510(k) clearances |
| Nov 21, 2006 | BIOAGGREGATEK063422 · KIF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
