# Septodont, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 21 (1976–2021): 21 510(k) clearances
- Names in FDA's records: Septodont, Inc. (11); Septodont (9); Septodont S.A.S. (1)
- Product codes: KIF (6), EMA (3), EIG (2), EJR (1), EJK (1), EJJ (1), ELW (1), MVL (1), LBH (1), KJJ (1), LYC (1)
- 510(k) review time since 2016: median 61 days, against 89 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Specialites Septodont: 1 (https://510kreport.com/company/specialites-septodont)
- Novocol, Inc.: 1 (https://510kreport.com/company/novocol)
- Innovative Bioceramix, Inc.: 1 (https://510kreport.com/company/innovative-bioceramix)

## Firms that cite its devices most
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)
- Parkell, Inc.: 1 (https://510kreport.com/company/parkell)
- Cytophil, Inc.: 1 (https://510kreport.com/company/cytophil)

## Its most-cited devices
- K093711: Racegel (2010), cited by 2
- K063634: RTR Syringe (2007), cited by 1
- K140132: Biodentine (2014), cited by 1

## Recent decisions
- K212283: BioRoot Flow 0.5g, BioRoot Flow 2g (Sep 16, 2021)
- K211799: Biodentine XP 500, Biodentine XP 200 (Aug 10, 2021)
- K172839: Endosolv (Feb 13, 2018)
- K140132: Biodentine (Jun 27, 2014)
- K093711: Racegel (Feb 17, 2010)
- K092251: Biodentine (Oct 30, 2009)
- K063634: RTR Syringe (May 11, 2007)
- K051010: Securalloy, Septalloy NG 50 and Septalloy NG 70 (May 2, 2005)

Source page: https://510kreport.com/company/septodont