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

EBL · Predicate Candidate Screening

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

41 daysmedian FDA review time

174 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K002693	CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HAN	Cbs Intl. B.V.	2000-11-09	72
K952868	DENTAURUM JACKET CROWN & ROOT POSTS	Dentauraum, Inc.	1995-07-19	27
K924376	ROOT CANAL POST	The Thera Group	1993-11-22	451
K895283	PROSTHETIC RESTORATION DEVICE	Swiss Precision Mfg. Corp.	1990-02-14	174
K895758	PLASTIC TOOTH REINFORCEMENT KIT	Nanzee Dental Products	1989-12-20	85
K883074	ELGILOY	Dale T. Dupuis	1988-08-09	26
K863831	VIVADENT FILPIN	Vivadent (Usa), Inc.	1986-10-14	14
K844457	SECURIPIN	Hughes Int'L, Inc.	1984-12-27	41
K830773	MARKLEY THREADED WIRE	Almore Intl., Inc.	1983-04-28	48
K822412	REINFORCING PIN	Filhol	1982-08-30	20
K760723	SAFE-T-PINS RETENTIVE PIN SYSTEM	Parkell, Inc.	1976-10-21	24

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