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

EHY — Predicate Candidate Screening

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

46 daysmedian FDA review time

88 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K942668	O-TRAY IMPRESSION TRAYS	Dentauraum, Inc.	1994-07-22	46
K896470	EOS IMPRESSION TRAYS	Ivoclar North America, Inc.	1990-02-09	88
K884316	OCCLUSAL HARMONY IMPRESSION TRAY	Advantage Dental Co.	1988-12-22	70
K863836	POST TRAY	Market Masters, Inc.	1986-10-14	14
K850776	PREFORMED DENTAL IMPRESSION TRAYS	L.A.K. Ent., Inc.	1985-03-18	20
K842273	CROWN INDEX TRAY	Di-Equi Dental Products	1984-07-31	53
K842274	F-G-P TRAY	Di-Equi Dental Products	1984-07-31	53
K841491	CONVENTIONAL PLASTIC DENTAL TRAYS	Buffalo Dental Mfg. Co., Inc.	1984-07-13	94
K841323	FUZZY TRAY	Buffalo Dental Mfg. Co., Inc.	1984-06-27	86
K833485	IMPRESSION TUBE ADJUSTABLE	Zefr, Inc.	1983-12-26	80
K810524	SR-IVOTRAY SPECIAL	J. Aderer, Inc.	1981-03-17	19
K810525	SR-IVOTRAY UNIVERSAL	J. Aderer, Inc.	1981-03-17	19
K801548	PERF-LOCK IMPRESSION TRAY	Dentsply Intl.	1980-07-21	14
K800900	PREMIER TRIPLE TRAY	Premier Dental Products Co.	1980-04-29	11
K780678	IMPRESSION TRAY	Rocky Mountain Orthodontics, Inc.	1978-04-28	4
K780211	4-IN-1 DISP. CROWN & BRIDGE TRAY	Kerr Corporation (Danbury)	1978-02-16	8

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