510(k) Report

FDA applicant

Septodont, Inc.

Mchenry, IL21 decisions1976–20210 recalls

FDA records 21 decisions for Septodont, Inc. (Mchenry, IL) from 1976 to 2021: 21 510(k) clearances. Most are in product codes KIF (Resin, Root Canal Filling) and EMA (Cement, Dental). Since 2016 its 510(k)s took a median of 61 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Septodont”, “Septodont S.A.S.”.

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 Septodont, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2007: 12009: 12010: 12014: 12018: 12021: 2
2007high 2 (2021) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Septodont, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KIFResin, Root Canal Filling6decisions
  • EMACement, Dental3decisions
  • EIGRetractor, All Types2decisions
  • EJRAgent, Polishing, Abrasive, Oral Cavity1decision
  • EJKLiner, Cavity, Calcium Hydroxide1decision
  • EJJAlloy, Amalgam1decision

Also: ELW (1), MVL (1), LBH (1), KJJ (1), LYC (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 61 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K093711RacegelSeptodont · 20102cite it
  • K063634RTR SyringeSeptodont · 20071cites it
  • K140132BiodentineSeptodont · 20141cites it

What has FDA decided for it lately?

  • K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont · 2021
  • K211799Biodentine XP 500, Biodentine XP 200Septodont · 2021
  • K172839EndosolvSeptodont · 2018
  • K140132BiodentineSeptodont · 2014
  • K093711RacegelSeptodont · 2010
  • K092251BiodentineSeptodont · 2009
  • K063634RTR SyringeSeptodont · 2007
  • K051010Securalloy, Septalloy NG 50 and Septalloy NG 70Septodont · 2005

All 11 as Septodont, Inc. →All 9 as Septodont →The one decision as Septodont S.A.S. →