Cleanser, Denture, Over The Counter

FDA product code EFT · Class I (low risk) · 21 CFR 872.3520 · Dental

26510(k) clearances
0PMA approvals
3recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K080631Cleanse.Freshen.Go; Aligner Cleansing Towelette and Dental Appliance CleanserEFT · Traditional Oral Health Technologies, LLC05/23/2008SE
K051342Medical InterporousEFT · Traditional Bonyf AG06/02/2006SE
K000996Trubyte Denture Cleanser/Polishing CompoundEFT · Traditional Dentsply Intl.06/16/2000SE
K942203OTC Denture CleanserEFT · Traditional Combe, Inc.08/10/1994SE
K930337Profast(R)-Denture CleanserEFT · Traditional Fittydent-Altwirth & Schmitt GmbH09/07/1993SE
K914257Denture Product XEFT · Traditional Essential Dental Systems, Inc.01/13/1993SE
K925259CFR MonographEFT · Traditional Combe, Inc.01/11/1993SE
K902838Denture Dynamic's Denture MagicEFT · Traditional Denture Dynamic'S, Inc.09/06/1990SE
K903686Argilite 4 Gold Alloy for PorcelainEFT · Traditional Argen Precious Metals, Inc.08/29/1990SE
K895345Orad Toothbrush CleanerEFT · Traditional Orad, Inc.03/07/1990SE
K890043Dentclean Concentrated Denture CleanserEFT · Traditional K-P Co.06/07/1989SE
K890668Clean DentEFT · Traditional Lincoln Park Dental Laboratory04/17/1989SE
K880068Effervescent Denture CleanserEFT · Traditional Perrigo Co.03/07/1988SE
K874805Tatung's Denture Cleaning SolutionEFT · Traditional Tatung Company of America, Inc.02/16/1988SE
K871785Denture Cleansing TabletEFT · Traditional Pennex Products Co., Inc.09/11/1987SE
K854995DenclenzEFT · Traditional Creighton Products Corp.05/12/1986SE
K860118Sunbeam Ultrasonic Denture Cleaner Model 4220EFT · Traditional Northern Electric Co. Div. of Sunbeam Corp.04/17/1986SE
K860737Teen Clean, Retainer CleanerEFT · Traditional Teen Care, Inc.03/26/1986SE
K851183Pepsodent Denture Cleanser PDP FormulaEFT · Traditional Lever Brothers Company, Inc.04/29/1985SE
K851182Pepsodent Denture Cleanser-Westone FormulaEFT · Traditional Lever Brothers Company, Inc.04/29/1985SE
K844572Pre-Klene Enamel CleanerEFT · Traditional Medical Products Laboratories, Inc.01/18/1985SE
K841801Denture CleanserEFT · Traditional Miracle Clean, Inc.06/22/1984SE
K820020Spryce, Denture CleanserEFT · Traditional Richardson-Vicks, Inc.01/22/1982SE
K810279Denture CleanerEFT · Traditional Mcdennan Oral Products, Inc.02/23/1981SE
K791064Duo Two Layer Denture CleanserEFT · Traditional Block Drug Company, Inc.10/09/1979SE
K772087Ultrasonic Denture CleanerEFT · Traditional Clairol, Inc.11/14/1977SE

Recalls

RecallProductFirmInitiated
Z-0267-2024 Class IIGOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB…Products were stored outside of labeled temperature requirements. Family Dollar Stores, Llc.10/04/2023Open, Classified
Z-1544-2022 Class IIPOLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… Family Dollar Stores, Llc.06/23/2022Open, Classified
Z-1534-2022 Class IIGS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT, SKU 906023Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… Family Dollar Stores, Llc.06/23/2022Open, Classified