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

EJP — Predicate Candidate Screening

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

33 daysmedian FDA review time

105 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K926190	ALRAND INC. (DENTAL HAND INSTRUMENTS)	Alrand, Inc.	1994-01-18	405
K896131	GNATHOMAT ARTICULATOR	Ivoclar North America, Inc.	1989-12-04	42
K892373	DENTAL PLASTIC BITE FORK	Texapol Corp.	1989-06-12	67
K884418	PREMIER DIE-TRAK ARTICULATOR	Premier Medical	1988-11-14	25
K872943	DISPOSABLE ARTICULATOR	Dentsply Intl.	1987-08-11	14
K863009	GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX	Sds Dental, Inc.	1986-09-25	48
K854702	PLASTIC MOUNTING RINGS	Almore Intl., Inc.	1986-03-06	105
K833039	HANDY IIM	Shofu Dental Corp.	1983-10-04	28
K811075	BALANCE ARTICULATOR	Almore Intl., Inc.	1981-05-13	23
K810971	THE GNATOMET	Bauer, Cheng & Associates, Inc.	1981-05-05	26
K801342	DISPOSABLE ARTICULATOR	Williams Gold Refining Co., Inc.	1980-07-08	33

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