Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Septodont — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

79 daysmedian FDA review time

161 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K212283	BioRoot Flow 0.5g, BioRoot Flow 2g	Septodont	2021-09-16	57
K211799	Biodentine XP 500, Biodentine XP 200	Septodont	2021-08-10	61
K172839	ENDOSOLV	Septodont	2018-02-13	147
K140132	BIODENTINE	Septodont	2014-06-27	161
K093711	RACEGEL	Septodont	2010-02-17	78
K092251	BIODENTINE	Septodont	2009-10-30	94
K063634	RTR SYRINGE	Septodont	2007-05-11	156
K051010	SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70	Septodont	2005-05-02	11
K032708	PLASTALGIN AND PLASTALGIN ORTHO	Septodont	2003-11-20	79

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda