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

EFT — Predicate Candidate Screening

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

80 daysmedian FDA review time

228 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K080631	CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL A	Oral Health Technologies, LLC	2008-05-23	79
K051342	MEDICAL INTERPOROUS	Bonyf AG	2006-06-02	375
K000996	TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND	Dentsply Intl.	2000-06-16	80
K942203	OTC DENTURE CLEANSER	Combe, Inc.	1994-08-10	97
K930337	PROFAST(R)-DENTURE CLEANSER	Fittydent-Altwirth & Schmitt GmbH	1993-09-07	228
K914257	DENTURE PRODUCT X	Essential Dental Systems, Inc.	1993-01-13	478
K925259	CFR MONOGRAPH	Combe, Inc.	1993-01-11	84
K902838	DENTURE DYNAMIC'S DENTURE MAGIC	Denture Dynamic'S, Inc.	1990-09-06	70
K903686	ARGILITE 4 GOLD ALLOY FOR PORCELAIN	Argen Precious Metals, Inc.	1990-08-29	16
K895345	ORAD TOOTHBRUSH CLEANER	Orad, Inc.	1990-03-07	188
K890043	DENTCLEAN CONCENTRATED DENTURE CLEANSER	K-P Co.	1989-06-07	153
K890668	CLEAN DENT	Lincoln Park Dental Laboratory	1989-04-17	67
K880068	EFFERVESCENT DENTURE CLEANSER	Perrigo Co.	1988-03-07	56
K874805	TATUNG'S DENTURE CLEANING SOLUTION	Tatung Company of America, Inc.	1988-02-16	85
K871785	DENTURE CLEANSING TABLET	Pennex Products Co., Inc.	1987-09-11	128
K854995	DENCLENZ	Creighton Products Corp.	1986-05-12	151
K860118	SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220	Northern Electric Co. Div. of Sunbeam Corp.	1986-04-17	94
K860737	TEEN CLEAN, RETAINER CLEANER	Teen Care, Inc.	1986-03-26	27
K851183	PEPSODENT DENTURE CLEANSER PDP FORMULA	Lever Brothers Company, Inc.	1985-04-29	34
K851182	PEPSODENT DENTURE CLEANSER-WESTONE FORMULA	Lever Brothers Company, Inc.	1985-04-29	34
K844572	PRE-KLENE ENAMEL CLEANER	Medical Products Laboratories, Inc.	1985-01-18	56
K841801	DENTURE CLEANSER	Miracle Clean, Inc.	1984-06-22	52
K820020	SPRYCE, DENTURE CLEANSER	Richardson-Vicks, Inc.	1982-01-22	17
K810279	DENTURE CLEANER	Mcdennan Oral Products, Inc.	1981-02-23	21
K791064	DUO TWO LAYER DENTURE CLEANSER	Block Drug Company, Inc.	1979-10-09	120
K772087	ULTRASONIC DENTURE CLEANER	Clairol, Inc.	1977-11-14	11

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