Product Code: EFT FDA class 1 21 CFR 872.3520

Cleanser, Denture, Over The Counter

Dental

The Over-the-Counter Denture Cleanser is a consumer dental product used to remove stains, plaque, bacteria, and food deposits from removable dentures through chemical or mechanical action, typically in the form of tablets, powders, or solutions used in soaking. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EFT and the applicable regulation is 21 CFR 872.3520, under the Dental medical specialty.

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510(k)s

FEI Numbers

126

Registration Numbers

127

Unique Applicants

Years Active

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Basic Information

Product Code: EFT
Device Class: FDA class 1
Regulation Number: 872.3520
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K080631	CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER	May 23, 2008	Substantially Equivalent	Oral Health Technologies, LLC
K051342	MEDICAL INTERPOROUS	Jun 02, 2006	Substantially Equivalent	Bonyf AG
K000996	TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND	Jun 16, 2000	Substantially Equivalent	Dentsply Intl.
K942203	OTC DENTURE CLEANSER	Aug 10, 1994	Substantially Equivalent	Combe, Inc.
K930337	PROFAST(R)-DENTURE CLEANSER	Sep 07, 1993	Substantially Equivalent	Fittydent-Altwirth & Schmitt GmbH
K914257	DENTURE PRODUCT X	Jan 13, 1993	Substantially Equivalent	Essential Dental Systems, Inc.
K925259	CFR MONOGRAPH	Jan 11, 1993	Substantially Equivalent	Combe, Inc.
K902838	DENTURE DYNAMIC'S DENTURE MAGIC	Sep 06, 1990	Substantially Equivalent	Denture Dynamic'S, Inc.
K903686	ARGILITE 4 GOLD ALLOY FOR PORCELAIN	Aug 29, 1990	Substantially Equivalent	Argen Precious Metals, Inc.
K895345	ORAD TOOTHBRUSH CLEANER	Mar 07, 1990	Substantially Equivalent	Orad, Inc.
K890043	DENTCLEAN CONCENTRATED DENTURE CLEANSER	Jun 07, 1989	Substantially Equivalent	K-P Co.
K890668	CLEAN DENT	Apr 17, 1989	Substantially Equivalent	Lincoln Park Dental Laboratory
K880068	EFFERVESCENT DENTURE CLEANSER	Mar 07, 1988	Substantially Equivalent	Perrigo Co.
K874805	TATUNG'S DENTURE CLEANING SOLUTION	Feb 16, 1988	Substantially Equivalent	Tatung Company of America, Inc.
K871785	DENTURE CLEANSING TABLET	Sep 11, 1987	Substantially Equivalent	Pennex Products Co., Inc.
K854995	DENCLENZ	May 12, 1986	Substantially Equivalent	Creighton Products Corp.
K860118	SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220	Apr 17, 1986	Substantially Equivalent	Northern Electric Co. Div. of Sunbeam Corp.
K860737	TEEN CLEAN, RETAINER CLEANER	Mar 26, 1986	Substantially Equivalent	Teen Care, Inc.
K851183	PEPSODENT DENTURE CLEANSER PDP FORMULA	Apr 29, 1985	Substantially Equivalent	Lever Brothers Company, Inc.
K851182	PEPSODENT DENTURE CLEANSER-WESTONE FORMULA	Apr 29, 1985	Substantially Equivalent	Lever Brothers Company, Inc.
K844572	PRE-KLENE ENAMEL CLEANER	Jan 18, 1985	Substantially Equivalent	Medical Products Laboratories, Inc.
K841801	DENTURE CLEANSER	Jun 22, 1984	Substantially Equivalent	Miracle Clean, Inc.
K820020	SPRYCE, DENTURE CLEANSER	Jan 22, 1982	Substantially Equivalent	Richardson-Vicks, Inc.
K810279	DENTURE CLEANER	Feb 23, 1981	Substantially Equivalent	Mcdennan Oral Products, Inc.
K791064	DUO TWO LAYER DENTURE CLEANSER	Oct 09, 1979	Substantially Equivalent	Block Drug Company, Inc.
K772087	ULTRASONIC DENTURE CLEANER	Nov 14, 1977	Substantially Equivalent	Clairol, Inc.