Prosthetic devices · 21 CFR 872 Subpart D
Over the Counter Denture Cleanser
FDA device type “Cleanser, Denture, Over The Counter”.
- Companies listing it
- 11580 makers
- Brands and models
- 250
- 510(k) clearances
- 260 in five years
- FDA name
- Cleanser, Denture, Over The Counter
510(k) clearances per year, 1976–2026
Companies that list EFT
115 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Align Technology, Inc. | United States | Maker | Cleaning Crystals, Packette | 16 | 2026 |
| Kulzer, LLC | United States | Maker | Pala Brillance Denture Cleanser · Venus Rapid Fresh Cleanser | 37 | 2026 |
| Prevest Denpro Limited | India | Maker | Oradox Aligners and Retainers Cleansing Tabs · Oradox Denture Cleansing Tabs | 7 | 2024 |
| Cavex Holland BV | Netherlands | Maker | Cavex GreenClean | 26 | 2015 |
| Procter & Gamble | United States | Maker | — | 16 | 2020 |
| Thermoplastic Comfort Systems, Inc. | United States | Maker | TCS Fresh Concentrated Dental Appliance Cleaner | 3 | 2015 |
| Manufacturera Dental Continental | Mexico | Maker | Confident Denture Cleaner | 2 | 2001 |
| Protech Professional Products, Inc. | United States | Maker | PROTECH CONCENTRAT · SMILE AGAIN | 2 | 2015 |
| Tower Laboratories, Ltd. | United States | Maker | All Smiles Denture Tablets · Best Choice Effervescent Denture Cleanser Anti-Bacterial · Best Choice Effervescent Denture Cleanser Anti-Bacterial 3-Minute · Bi-mart Effervescent Denture Cleanser Anti-Bacterial · +81 | 1 | 1983 |
| Prestige Brands Holdings, Inc. | United States | Maker | Efferdent Coffee and Tea · Efferdent Complete Clean Denture Cleanser · Efferdent Denture Cleanser Coffee and Tea · Efferdent Denture Cleanser Original · +5 | 1 | 2013 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | Cleanser, Denture, Denture Cleanser, denture cleaning tablets | 1 | 2020 |
| Bonyf AG | Liechtenstein | Maker | NitrAdine Disinfecting Tablets - DENTTACH CLEAN | 1 | 2006 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Cleaning Tablet | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | Dentasoak | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | Cleaning Tablet | — | — |
| Jiangxi IVISMILE Technology Co.,Ltd | China | Maker | Denture Cleansing Tablet | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Denture cleansing tablet · Interdental brush | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Denture Cleansing Tablet | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Denture Cleansing Tablet | — | — |
| Jiangxi Dentalbright Technology Co., Ltd | China | Maker | Denture Cleansing Tablet, Aligner Cleaner | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Denture Cleansing Tablet, Aligner Cleaner | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Denture Cleanser Tablets | — | — |
| Produits Dentaires SA | Switzerland | Maker | Disclosing Tablets · Effervescent Mouth Wash Tablets, Pink | — | — |
| one day dental partner | South Korea | Maker | kage cleanser | — | — |
| Everbrands, Inc. | United States | Maker | BrightByte · Candid Whitening Foam · EverSmile Aligner Fresh · EverSmile Aligner Fresh Spray · +8 | — | — |
| Ekong Technology Co., Limited. | China | Maker | Denture Cleansing Tablet | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Denture Cleansing Tablet | — | — |
| Anhui Greenland Biotech Co.,Ltd | China | Maker | aligner cleaner · Avistar · cleaning tablets · DENTAL CHECK · +13 | — | — |
| Erskine Dental | Australia | Maker | Oral Appliance Cleaning Tablets | — | — |
| DOC BRANDS, Inc. | United States | Maker | Clean-It | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | Denture Cleansing Tablet/Aligner Cleaner | — | — |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | China | Maker | Denture Cleansing Tablet | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Denture Cleanser | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | mouthwash tablets, Oil Pulling, Cleaning Crystals, Toothpaste Tablet, DSI Oil Pulling · Mouthwash, mouth spray, denture cleansing tablets, mouth tray cleaner, aligner cleaner, cleaning tablets, | — | — |
| Haleon | United States | Maker | DENTURE CLEANSERS (VARIOUS) · Polident · Polident 3 Minute: Antibacterial Dental Appliance Cleanser · Polident Cleaner · +4 | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | Mouthwash, Denture cleansing tablets, Cleanser, Denture, Denture Cleanser | — | — |
| Dukal Corporation | United States | Maker | DawnMist Denture Cleanser Tablets | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Denture Cleanser | — | — |
| Kingkey MBC Life Technology Group Co.,Ltd. | China | Maker | Acne treatment facil cream · Acne treatment facil wash · Acne treatment toner · MOUTHWASH | — | — |
| Shenzhen Balinda Technology Co.,Ltd | China | Maker | Denture Cleaning Tablet, Denture Cleanser | — | — |
| Sheffield Pharmaceuticals LLC | United States | Maker | Cleanadent | — | — |
| PHS Do Brasil LTDA | Brazil | Maker | POTENZA CLOUD CLEAN | — | — |
| Shenzhen Mold and Manufacturing Co Ltd | China | Maker | Beaming White | — | — |
| Fittydent Int. GmbH | Austria | Maker | PROFAST DENTURE CLEANER · PROFAST DENTURE CLEANSER · Secure Denture Cleanser · Secure orthodontic Cleansing Tablets | — | — |
| Weihai Jieshi Commodity Manufacture Co., Ltd. | China | Maker | Denture cleaner, Denture clean tablets | — | — |
| Xingyue Medical Health Technology (Nanjing) Co., Ltd . | China | Maker | Denture&Retainer Cleanser/Tablets | — | — |
| Weihai Huihai Commodity Manufacture Co., Ltd. | China | Maker | Stain remover | — | — |
| Gurunanda LLC | United States | Maker | GuruNanda Aligner and Retainer Cleaning Foam · Invisalign Aligner Cleaning Foam | — | — |
| iSonic Inc. | United States | Maker | iSonic® AlignClean Ultrasonic Cleaning Tablet · iSonic® Green Natural Ultrasonic Denture Cleanser · iSonic® White Ultrasonic Denture Cleanser | — | — |
| Foshan Ousidun Personal Care Products Co.,Ltd | China | Maker | Denture Cleanser | — | — |
| New World Imports, Inc. | United States | Maker | Freshmint | — | — |
| Changzhou Freshday Household Products Corp. Ltd. | China | Maker | — | — | — |
| Kakawa USA Corp | United States | Maker | BLD Dental Floss | — | — |
| North Eos Industries Inc | Taiwan | Maker | DentBox · EOS BRAND | — | — |
| OrVance LLC | United States | Maker | OrVance Retainer Cleaner | — | — |
| Yangzhou Sinje Biotechnology Co.,Ltd | China | Maker | Cleanser, Denture, over the counter | — | — |
| Yangzhou star oral care product co., ltd. | China | Maker | — | — | — |
| Hangzhou Namei Zhikang Technology Co., Ltd. | China | Maker | Electric Mouthwash Oral Irrigator:E31 | — | — |
| Havpak, Inc. | United States | Maker | — | — | — |
| Movemints, LLC | United States | Maker | Movemints Aligner and Retainer Cleaning Tablets | — | — |
| Wisdom Toothbrushes Ltd. | United Kingdom | Maker | Wisdom denture bath (3 piece) | — | — |
| Yancheng Trancom First Aid Supplies Industrial Co., Ltd | China | Maker | Skin cleaning wipes | — | — |
| Diamond Wipes International, Inc. | United States | Maker | TCS Concentrated Dental Appliance Cleaner · TCS Concentrated Denture Cleaner | — | — |
| Jiaoyue Pharmaceutical (Huizhou) Co.ltd | China | Maker | mouthwash | — | — |
| KP Dental LLC | United States | Maker | Zima Tablets | — | — |
| MicroCare, LLC | United States | Maker | Tartar & Stain Remover · Tartar & Stain Remover Super Concentrated | — | — |
| Novalab Inc. | Canada | Maker | Brushguard · Novadent | — | — |
| Regent Labs, Inc. | United States | Maker | KLEENITE · STAIN AWAY PLUS | — | — |
| Brushee LLC | United States | Maker | Brushee Retainer & Aligner Cleaner | — | — |
| Cory Labs | United States | Maker | Cory Labs | — | — |
| Goran Pharma Pvt. Ltd. | India | Maker | Fresh'n Brite Denture Cleaning Paste | — | — |
| Hubei Kangcheng Non-Woven Co Ltd | China | Maker | cleanser, denture, over the counter | — | — |
| LMA Solutions Inc. | United States | Maker | dentibrite | — | — |
| Mid-Continental Dental Supply Co. Ltd. | Canada | Maker | Renew Denture Cleaner | — | — |
| Ningbo Favored Commodity Co.,ltd | China | Maker | Caring Mill Retainer Cleaning Tablets | — | — |
| Redi-2-PaQ Home Products, LLC | United States | Maker | Smilesaver Spearmint Spary 30 ml (1flo2) | — | — |
| Accupac, LLC | United States | Maker | — | — | — |
| Akervall Technologies Inc. | United States | Maker | — | — | — |
| Andpak, Inc | United States | Maker | — | — | — |
| Park Dental Research Corp | United States | Contract manufacturer | Denture Cleansing Tablet | 8 | 2026 |
| Somnomed, Inc. | United States | Manufacturer | SomTabs | 11 | 2026 |
| Ortho Organizers, Inc. | United States | Manufacturer | — | 8 | 2025 |
| Sleeping Well, LLC | United States | Repacker / relabeler | ZQuiet Clean | 6 | 2022 |
| Myofunctional Research Co. Usa Inc. | United States | Foreign exporter | MyoClean | 3 | 2026 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | — | 2 | 2025 |
| Valplast Intl. Corp. | United States | Manufacturer | Val-Clean | 1 | 2006 |
| Perflex Ltd | Israel | Manufacturer | Flexiclean | 1 | 2015 |
| Perma Laboratories | United States | Manufacturer | Fizz-It Denture Cleaner | 1 | 2012 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Ultrasonic Cleaning | — | — |
| Daiso USA LLC | United States | Foreign exporter | Denture Cleansing Tablet | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Ultrasonic Cleaning | — | — |
| Ortho Dental Lab, LLC | United States | Manufacturer | SmileSet Universal Cleaning Tablets | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Beaming White LLC | United States | Manufacturer | Beaming White | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | Denture Cleanser | — | — |
| WSD Labs Usa Inc. | United States | Repacker / relabeler | Denture Cleansing Tablet | — | — |
| Summit Packaging Solutions LLC | United States | Repacker / relabeler | Over The Counter Denture Cleanser | — | — |
| Axiom Marketing, Inc. | United States | Repacker / relabeler | Invisalign Aligner Cleaning Foam · Invisalign Aligner Cleaning Spray · Invisalign Cleaning Crystals · Invisalign Cleaning Crystals + · +2 | — | — |
| WestRock Converting, LLC | United States | Repacker / relabeler | FIXODENT | — | — |
| HiSmile Pty Ltd | Australia | Foreign exporter | Hismile Germ Warfare Dental Appliance Cleaning Powder | — | — |
| Libodent Inc. | United States | Repacker / relabeler | Metal frame partial · Valplast | — | — |
| Planet(Shanghai) international Co.,Ltd | China | Foreign exporter | CLEANSER, DENTURE, OVER THE COUNTER | — | — |
| Gda Marketing Limited | Hong Kong SAR China | Foreign exporter | Fresh 'N Brite | — | — |
| Jack Jack LLC | United States | Lister | Aligner Cleaner | — | — |
| Ryder Integrated Logistics, INC | United States | Repacker / relabeler | — | — | — |
| LG Management Dental Lab, Inc. | United States | Repacker / relabeler | LG Management Dental Lab | — | — |
| VIVE Health LLC | United States | Repacker / relabeler | Denture Cleaning Tablets | — | — |
| Honest Pharma LLC | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Natural Dentist LLC | United States | Repacker / relabeler | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| RespLabs Medical USA Inc. | United States | Lister | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 May 2008 | K080631 | CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER | Oral Health Technologies, LLC |
| 2 Jun 2006 | K051342 | MEDICAL INTERPOROUS | Bonyf AG |
| 16 Jun 2000 | K000996 | TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND | Dentsply Intl., Inc. |
| 10 Aug 1994 | K942203 | OTC DENTURE CLEANSER | Combe, Inc. |
| 7 Sep 1993 | K930337 | PROFAST(R)-DENTURE CLEANSER | Fittydent-Altwirth & Schmitt GmbH |
| 13 Jan 1993 | K914257 | DENTURE PRODUCT X | Essential Dental Systems, Inc. |
| 11 Jan 1993 | K925259 | CFR MONOGRAPH | Combe, Inc. |
| 6 Sep 1990 | K902838 | DENTURE DYNAMIC'S DENTURE MAGIC | Denture Dynamic'S, Inc. |
| 29 Aug 1990 | K903686 | ARGILITE 4 GOLD ALLOY FOR PORCELAIN | Argen Precious Metals, Inc. |
| 7 Mar 1990 | K895345 | ORAD TOOTHBRUSH CLEANER | Orad, Inc. |
| 7 Jun 1989 | K890043 | DENTCLEAN CONCENTRATED DENTURE CLEANSER | K-P Co. |
| 17 Apr 1989 | K890668 | CLEAN DENT | Lincoln Park Dental Laboratory |
| 7 Mar 1988 | K880068 | EFFERVESCENT DENTURE CLEANSER | Perrigo Co. |
| 16 Feb 1988 | K874805 | TATUNG'S DENTURE CLEANING SOLUTION | Tatung Company of America, Inc. |
| 11 Sep 1987 | K871785 | DENTURE CLEANSING TABLET | Pennex Products Co., Inc. |
| 12 May 1986 | K854995 | DENCLENZ | Creighton Products Corp. |
| 17 Apr 1986 | K860118 | SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 | Northern Electric Co. Div. of Sunbeam Corp. |
| 26 Mar 1986 | K860737 | TEEN CLEAN, RETAINER CLEANER | Teen Care, Inc. |
| 29 Apr 1985 | K851183 | PEPSODENT DENTURE CLEANSER PDP FORMULA | Lever Brothers Company, Inc. |
| 29 Apr 1985 | K851182 | PEPSODENT DENTURE CLEANSER-WESTONE FORMULA | Lever Brothers Company, Inc. |
| 18 Jan 1985 | K844572 | PRE-KLENE ENAMEL CLEANER | Medical Products Laboratories, Inc. |
| 22 Jun 1984 | K841801 | DENTURE CLEANSER | Miracle Clean, Inc. |
| 22 Jan 1982 | K820020 | SPRYCE, DENTURE CLEANSER | Richardson-Vicks, Inc. |
| 23 Feb 1981 | K810279 | DENTURE CLEANER | Mcdennan Oral Products, Inc. |
| 9 Oct 1979 | K791064 | DUO TWO LAYER DENTURE CLEANSER | Block Drug Company, Inc. |
| 14 Nov 1977 | K772087 | ULTRASONIC DENTURE CLEANER | Clairol, Inc. |
Official records: FDA product classification for EFT · 21 CFR 872.3520.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026