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

JER — Predicate Candidate Screening

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

52 daysmedian FDA review time

144 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K883403	DENTA PLUS	Connoisseurs Products Corp.	1988-10-25	75
K881391	ULTRASONIC DENTURE CLEANER	Tatung Company of America, Inc.	1988-08-26	144
K872521	DENTURE CLEANSERS	Dental Research Laboratories	1987-08-11	47
K852906	DURACLEAN DENTURE CLEANER	Astron Dental Corp.	1985-07-31	22
K840805	ORAL SAFE	Great Lakes Orthodontics, Ltd.	1984-03-30	35
K832359	ORAL SAFE	Great Lakes Orthodontics, Ltd.	1983-09-26	70
K832387	DENTURE CLEANER	Tower Laboratories, Ltd.	1983-09-12	55
K800166	DENTSPLY DENTURE CLEANER	Dentsply Intl.	1980-03-17	52
K792530	PLAQUE-X DENTURE CLEANER	Nexell Corp.	1979-12-27	20
K791925	DEN-MAT 4-MINUTE DENTURE CLEANER	Den-Mat Corp.	1979-10-26	29
K791716	PLAQUE-X DENTURE CLEANSER	Noxell	1979-10-23	53
K781779	SANI-DENT DENTURE CLEANER	Sandi-Dent	1978-11-08	156
K780254	DENTURE CLEANSER & TOOTHPASTE IN ONE	Richardson Merrel, Inc.	1978-03-09	21
K780174	ORABRITE	Norcliff Thayer, Inc.	1978-02-23	21

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