Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Septodont and its 3 subsidiaries with 32 510(k) clearances, 11 drug recalls, 9 drug applications and 2 device recalls. The most recent is a 510(k) clearance dated Sep 16, 2021: BioRoot Flow 0.5g, BioRoot Flow 2g.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Septodont and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 16, 2021 | BioRoot Flow 0.5g, BioRoot Flow 2gK212283 · KIF | 510(k) clearances |
| Aug 10, 2021 | Biodentine XP 500, Biodentine XP 200K211799 · KIF | 510(k) clearances |
| Feb 13, 2018 | ENDOSOLVK172839 · KIF | 510(k) clearances |
| Nov 14, 2014 | BULK FILL FLOWABLE COMPOSITEK141994 · EBF | 510(k) clearances |
| Jul 16, 2014 | Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restoClass II · Septodont is recalling Self-Etch bond because the material was incorrectly packaged. | Device recalls |
| Jul 16, 2014 | Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a produClass II · Septodont is recalling Self-Etch bond because the material was incorrectly packaged. | Device recalls |
| Jun 27, 2014 | BIODENTINEK140132 · KIF | 510(k) clearances |
| Oct 17, 2013 | BIOROOT RCSK130601 · KIF | 510(k) clearances |
| Aug 14, 2013 | Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7Class II · Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 1 | Drug recalls |
| Dec 11, 2012 | BPA-FREE MICROHYBID COMPOSITEK120237 · EBF | 510(k) clearances |
| Jul 31, 2012 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENTK120283 · EMA | 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
