Septodont Inc.
FDA Regulatory Profile
Septodont Inc. appears in FDA public data with 2 recalls, 21 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1307-2019, Class II) was initiated on May 2, 2019. Its most recent 510(k) clearance was granted on September 16, 2021.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 21
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1307-2019 | Class II | Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, | May 2, 2019 |
| D-0828-2018 | Class III | OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4 | April 13, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | September 16, 2021 |
| K211799 | Biodentine XP 500, Biodentine XP 200 | August 10, 2021 |
| K172839 | ENDOSOLV | February 13, 2018 |
| K140132 | BIODENTINE | June 27, 2014 |
| K093711 | RACEGEL | February 17, 2010 |
| K092251 | BIODENTINE | October 30, 2009 |
| K063634 | RTR SYRINGE | May 11, 2007 |
| K051010 | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 | May 2, 2005 |
| K032708 | PLASTALGIN AND PLASTALGIN ORTHO | November 20, 2003 |
| K023976 | ACROSEAL ROOT CANAL OR APICAL SEALER | January 30, 2003 |
| K780003 | ENDOSOLV E | January 20, 1978 |
| K771114 | NEUTROCIM | January 4, 1978 |
| K761355 | SELFAST | January 3, 1977 |
| K761354 | CIMPAT (PINK AND WHITE) | January 3, 1977 |
| K760799 | FLUOCAL GEL ORANGE | November 24, 1976 |
| K760798 | FLUOCAL GEL MINT | November 24, 1976 |
| K761024 | RACESTYPTINE RINGS | November 19, 1976 |
| K760658 | DETARTRINE P | September 27, 1976 |
| K760660 | HYDROL | September 27, 1976 |
| K760657 | RACESTYPTINE CORD | September 27, 1976 |