Septodont, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Septodont, Inc.” (first 1976, latest 2021), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 52 days. Since 2017 the median was 61 days, against 136 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 161 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 147 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 59 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Septodont, Inc. took a median 61 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | 5 | 5 |
| EMA | Cement, Dental | 3 | 3 |
| EIG | Retractor, All Types | 2 | 2 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| KJJ | Cleanser, Root Canal | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Plus 2 more product codes.
Review panels
- Dental (18)
Most recent Septodont, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | KIF | 2021-09-16 | 57 |
| K211799 | Biodentine XP 500, Biodentine XP 200 | KIF | 2021-08-10 | 61 |
| K172839 | ENDOSOLV | KIF | 2018-02-13 | 147 |
| K140132 | BIODENTINE | KIF | 2014-06-27 | 161 |
| K093711 | RACEGEL | MVL | 2010-02-17 | 78 |
| K092251 | BIODENTINE | KIF | 2009-10-30 | 94 |
| K063634 | RTR SYRINGE | LYC | 2007-05-11 | 156 |
| K051010 | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 | EJJ | 2005-05-02 | 11 |
| K032708 | PLASTALGIN AND PLASTALGIN ORTHO | ELW | 2003-11-20 | 79 |
| K780003 | ENDOSOLV E | KJJ | 1978-01-20 | 22 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Septodont, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Septodont, Inc. is the lead sponsor of 11 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:
- NCT06955429: Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications. (Recruiting, started 2025-10-23)
- NCT06467630: Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures (Active not recruiting, started 2024-02-09)
- NCT05536115: Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket (Completed, started 2022-12-13)
- NCT05614635: Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression (Completed, started 2022-10-12)
- NCT05247138: Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS. (Active not recruiting, started 2022-02-18)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Septodont S.A.S. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Septodont, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Septodont, Inc.” (first 1976, latest 2021), across 12 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Septodont, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Septodont, Inc. is 52 days. Since 2017: 61 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Septodont, Inc.?
The most frequent FDA product codes under this applicant name are KIF (Resin, Root Canal Filling, 5); EMA (Cement, Dental, 3); EIG (Retractor, All Types, 2).
Next steps
- See all 20 Septodont, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIF, Septodont, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.