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

EGY · Predicate Candidate Screening

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

43 daysmedian FDA review time

122 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K992896	DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530,	Dental X-Ray Support Systems, Inc.	1999-09-03	7
K955825	SMITH S-100 TIME & TEMPERATURE CONTROL	Smith Companies Dental Products	1996-04-05	101
K955643	ALARA IMAGING SYSTEM	Denoptix, Inc.	1996-03-01	80
K945682	PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL	Gendex Corp.	1995-02-09	80
K900156	AP201 DENTAL X-RAY FILM PROCESSOR	Allied Photo Products Co., Inc.	1990-05-14	122
K874118	MODEL 410 DENTAL X-RAY FILM PROCESSORS	Dent-X Co.	1987-11-06	28
K811211	YOSHIDA AP 100	Kaycor Intl., Ltd.	1981-06-16	43
K771433	AUTO. DEVEL. UNIT FOO DENTAL X-RAY	Ada Products Co., Inc.	1977-08-19	18
K770783	FILM PROCESSOR, AUTOMATIC	General Electric Co.	1977-05-10	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