510(k) Report

FDA applicant

Innovative Bioceramix, Inc.

Vancouver, Bc, CA8 decisions2006–20230 recalls

FDA records 8 decisions for Innovative Bioceramix, Inc. (Vancouver, Bc, CA) from 2006 to 2023: 8 510(k) clearances. All are in product code KIF (Resin, Root Canal Filling). Its devices cite 29 predicates, 14 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Innovative Bioceramix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12009: 22010: 12014: 12022: 12023: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovative Bioceramix, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KIFResin, Root Canal Filling8decisions

Whose devices does it build on?

Its devices cite 29 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 28 times; 14 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080917Iroot SPInnovative Bioceramix, Inc. · 200812cite it
  • K092715Iroot BP PlusInnovative Bioceramix, Inc. · 20095cite it
  • K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 20095cite it
  • K063422BioaggregateInnovative Bioceramix, Inc. · 20064cite it
  • K102867Iroot FSInnovative Bioceramix, Inc. · 20102cite it

What has FDA decided for it lately?

  • K231259iRoot SP PlusInnovative Bioceramix, Inc. · 2023
  • K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root…Innovative Bioceramix, Inc. · 2022
  • K130312Iroot FMInnovative Bioceramix, Inc. · 2014
  • K102867Iroot FSInnovative Bioceramix, Inc. · 2010
  • K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009
  • K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
  • K080917Iroot SPInnovative Bioceramix, Inc. · 2008
  • K063422BioaggregateInnovative Bioceramix, Inc. · 2006

All 8 as Innovative Bioceramix, Inc. →