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

EAG — Predicate Candidate Screening

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

84 daysmedian FDA review time

468 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K030699	VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHAL	J. Morita Mfg. Corp.	2003-05-29	84
K021372	VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABI	J. Morita USA, Inc.	2002-06-07	38
K944162	DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM	Teledyne Water Pik	1994-11-29	95
K920189	GX-C CEPHALOMETER	Gendex Corp.	1992-04-28	104
K896099	DIGIGRAPH DIAGNOSTIC WORK/STATION	Dolphin Imaging Systems	1991-01-31	468
K870243	BURNETT TMJ APPLIANCE	Medrad, Inc.	1987-02-24	34
K842463	GX CEPH	Gendex Corp.	1984-08-02	41
K833006	CEPHALOMETER & FIXATOR	Modern Systems, Inc.	1984-01-03	119
K810538	PLASTICEPH	Morningstar Dental Co.	1981-04-29	62
K781287	DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH	Siemens Corp.	1978-09-11	47

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