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

EGZ · Predicate Candidate Screening

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

59 daysmedian FDA review time

158 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K913168	SALIBAG	Nix Co. , Ltd.	1991-09-06	51
K913160	ID-TAB	Nix Co. , Ltd.	1991-09-06	51
K890355	DENTAL X-RAY BITE BLOCK	Bite-A-Block	1989-06-12	139
K853451	TROLL-BITE	Trollplast, Inc.	1986-01-21	158
K852170	EZX YELLOW, BLUE OR ORANGE	Strong Marketing	1985-09-05	108
K853005	S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM	The S. S. White Co.	1985-08-13	28
K813378	UNI-BITE DENTAL X-RAY FILM HOLDER	Rinn Corp.	1982-01-29	59
K801079	KWIX-BITE X-RAY FILM HOLDER	Henry Schein, Inc.	1980-05-20	13

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