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

EKN — Predicate Candidate Screening

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

22 daysmedian FDA review time

162 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K843017	ABSORBENT ENDODONTIC POINT	United Dental Mfg., Inc.	1985-01-09	162
K821625	ENDODONTIC PAPERPOINTS	Roeko	1982-06-14	12
K812886	ENDODONTIC PAPER POINTS	United Dental Mfg., Inc.	1981-11-16	33
K800827	PREMIER ABSORBENT POINTS	Premier Dental Products Co.	1980-04-29	15
K781605	R&R ABSORBENT POINTS	Ransom and Randolph	1978-10-10	22
K761203	ABSORBENT POINTS	Johnson & Johnson Professionals, Inc.	1976-12-13	6
K760983	ENDODONTIC INSTRUMENTS	Adp Intl., Inc.	1976-11-15	25

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