Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

ELZ — Predicate Candidate Screening

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

52 daysmedian FDA review time

409 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K091362	CERAMIC PEDATRIC PREFORMED CROWN	Ez-Pedo, Inc.	2009-06-29	52
K932759	TEMPOARY POLYCARBONATE CROWNS	South American Dental Exporting Corp.	1994-07-22	409
K931352	PEDO JACKETS OR PJ'S	George M. Wilson, Dds	1993-07-21	126
K913152	WHITER BITER CROWN	George M. Wilson, Dds	1991-09-30	75
K912686	WHITER BITER CROWN	George M. Wilson, Dds	1991-09-16	90
K892893	SDI POLYCARBONATE CROWN, SCHEIN'S	Svenska Dental Instruments AB	1989-06-06	47
K883325	PERFORMED CROWN (STAINLESS STEEL)	Whitecap Dental Co.	1988-09-16	42
K771128	NEKO CERAMIC CONVENIENCE CROWNS	Sterndent Corp.	1977-07-15	22
K770684	CROWN, ACRYLIC, CORAL BRAND, PREFORMED	Parker Laboratories, Inc.	1977-04-26	14

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