Company ยท US
Septodont, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2021. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KIF | Resin, Root Canal Filling | 5 |
| EMA | Cement, Dental | 3 |
| EIG | Retractor, All Types | 2 |
| EJJ | Alloy, Amalgam | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 |
| ELW | Material, Impression | 1 |
| KJJ | Cleanser, Root Canal | 1 |
| LBH | Varnish, Cavity | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 |
| MVL | Cord, Retraction | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2021 | K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g Septodont, FR | KIF |
| Aug 10, 2021 | K211799 | Biodentine XP 500, Biodentine XP 200 Septodont, FR | KIF |
| Feb 13, 2018 | K172839 | ENDOSOLV Septodont | KIF |
| Jun 27, 2014 | K140132 | BIODENTINE Septodont | KIF |
| Feb 17, 2010 | K093711 | RACEGEL Septodont | MVL |
| Oct 30, 2009 | K092251 | BIODENTINE Septodont | KIF |
| May 11, 2007 | K063634 | RTR SYRINGE Septodont | LYC |
| May 2, 2005 | K051010 | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 Septodont | EJJ |
| Nov 20, 2003 | K032708 | PLASTALGIN AND PLASTALGIN ORTHO Septodont | ELW |
| Jan 20, 1978 | K780003 | ENDOSOLV E Septodont, Inc. | KJJ |
| Jan 4, 1978 | K771114 | NEUTROCIM Septodont, Inc. | EMA |
| Jan 3, 1977 | K761355 | SELFAST Septodont, Inc. | EMA |
| Jan 3, 1977 | K761354 | CIMPAT (PINK AND WHITE) Septodont, Inc. | EMA |
| Nov 24, 1976 | K760799 | FLUOCAL GEL ORANGE Septodont, Inc. | |
| Nov 24, 1976 | K760798 | FLUOCAL GEL MINT Septodont, Inc. | |
| Nov 19, 1976 | K761024 | RACESTYPTINE RINGS Septodont, Inc. | EIG |
| Sep 27, 1976 | K760660 | HYDROL Septodont, Inc. | LBH |
| Sep 27, 1976 | K760659 | CALCIPULPE Septodont, Inc. | EJK |
| Sep 27, 1976 | K760658 | DETARTRINE P Septodont, Inc. | EJR |
| Sep 27, 1976 | K760657 | RACESTYPTINE CORD Septodont, Inc. | EIG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||