Specialites Septodont: FDA clearances and approvals
Specialites Septodont has 21 FDA 510(k) clearances (first 1985, latest 2001), across 12 product codes in 2 review panels. Median 510(k) review time: 71 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMA | Cement, Dental | 8 | 8 |
| DZM | Needle, Dental | 2 | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | 2 | 2 |
| EAT | Tester, Pulp | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| EKJ | Burnisher, Operative | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| KIF | Resin, Root Canal Filling | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Plus 2 more product codes.
Review panels
- Dental (19)
- General Hospital (2)
Most recent Specialites Septodont 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | EAT | 2001-10-09 | 70 |
| K010415 | ISODAN | KLE | 2001-07-23 | 161 |
| K982773 | QUICKSET LIQUID AND POWDER | EMA | 1998-11-03 | 88 |
| K982671 | SECURALLOY | EJJ | 1998-10-19 | 80 |
| K980633 | ENDOSOLV E | KIF | 1998-05-01 | 71 |
| K920692 | SEPTOCALCINE ULTRA | EJK | 1992-04-21 | 67 |
| K915467 | CIMPAT S DENTAL CEMENT | EMA | 1992-02-03 | 60 |
| K915466 | SEPTOPACK TEMPORARY FILLING | EBG | 1992-02-03 | 60 |
| K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | DZM | 1991-11-07 | 87 |
| K913572 | AUTOPACK NON-EUGENOL PERIODONTAL DRESSING | EMA | 1991-10-09 | 58 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Specialites Septodont.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Specialites Septodont have?
Specialites Septodont has 21 FDA 510(k) clearances (first 1985, latest 2001), across 12 product codes in 2 review panels.
How long does FDA take to clear Specialites Septodont's 510(k)s?
The median time from FDA receipt to decision across Specialites Septodont's cleared 510(k)s is 71 days.
What devices does Specialites Septodont make?
Its most frequent FDA product codes are EMA (Cement, Dental, 8); DZM (Needle, Dental, 2); EJK (Liner, Cavity, Calcium Hydroxide, 2).
Has Specialites Septodont had device recalls?
openFDA lists no recalls under a recalling firm name matching Specialites Septodont. Related entities may recall under other names.
Next steps
- See all 21 Specialites Septodont clearances with predicates and recalls
- Run predicate analysis for product code EMA, Specialites Septodont's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.