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

EKR — Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

63 daysmedian FDA review time

335 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K060347	B&L L-BETA, MODEL WL-B1	B&L Biotech Co., Ltd.	2006-06-05	115	0
K042828	OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700	Young O/S, LLC	2004-12-01	50	0
K031664	ELEMENTS OBTURATION UNIT	Sybron Endo/Analytic	2004-04-28	335	2
K860569	ENDODONTIC ROOT CANAL PLUGGER	Dentsply Intl.	1986-03-26	43	0
K831748	ENDODONTIC ROOT CANAL PLUGGER FINGER-	Union Branch	1983-07-12	50	0
K791019	MCSPADDEN CONDENSOR	Techdent, Inc.	1979-08-03	63	0

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