Product code EFT
- Device name
- Cleanser, Denture, Over The Counter
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3520
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080631 | CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER | Oral Health Technologies, LLC | 2008-05-23 |
| K051342 | MEDICAL INTERPOROUS | Bonyf AG | 2006-06-02 |
| K000996 | TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND | Dentsply Intl. | 2000-06-16 |
| K942203 | OTC DENTURE CLEANSER | Combe, Inc. | 1994-08-10 |
| K930337 | PROFAST(R)-DENTURE CLEANSER | Fittydent-Altwirth & Schmitt GmbH | 1993-09-07 |
| K914257 | DENTURE PRODUCT X | Essential Dental Systems, Inc. | 1993-01-13 |
| K925259 | CFR MONOGRAPH | Combe, Inc. | 1993-01-11 |
| K902838 | DENTURE DYNAMIC'S DENTURE MAGIC | Denture Dynamic'S, Inc. | 1990-09-06 |
| K903686 | ARGILITE 4 GOLD ALLOY FOR PORCELAIN | Argen Precious Metals, Inc. | 1990-08-29 |
| K895345 | ORAD TOOTHBRUSH CLEANER | Orad, Inc. | 1990-03-07 |
| K890043 | DENTCLEAN CONCENTRATED DENTURE CLEANSER | K-P Co. | 1989-06-07 |
| K890668 | CLEAN DENT | Lincoln Park Dental Laboratory | 1989-04-17 |
| K880068 | EFFERVESCENT DENTURE CLEANSER | Perrigo Co. | 1988-03-07 |
| K874805 | TATUNG'S DENTURE CLEANING SOLUTION | Tatung Company of America, Inc. | 1988-02-16 |
| K871785 | DENTURE CLEANSING TABLET | Pennex Products Co., Inc. | 1987-09-11 |
| K854995 | DENCLENZ | Creighton Products Corp. | 1986-05-12 |
| K860118 | SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 | Northern Electric Co. Div. of Sunbeam Corp. | 1986-04-17 |
| K860737 | TEEN CLEAN, RETAINER CLEANER | Teen Care, Inc. | 1986-03-26 |
| K851182 | PEPSODENT DENTURE CLEANSER-WESTONE FORMULA | Lever Brothers Company, Inc. | 1985-04-29 |
| K851183 | PEPSODENT DENTURE CLEANSER PDP FORMULA | Lever Brothers Company, Inc. | 1985-04-29 |
| K844572 | PRE-KLENE ENAMEL CLEANER | Medical Products Laboratories, Inc. | 1985-01-18 |
| K841801 | DENTURE CLEANSER | Miracle Clean, Inc. | 1984-06-22 |
| K820020 | SPRYCE, DENTURE CLEANSER | Richardson-Vicks, Inc. | 1982-01-22 |
| K810279 | DENTURE CLEANER | Mcdennan Oral Products, Inc. | 1981-02-23 |
| K791064 | DUO TWO LAYER DENTURE CLEANSER | Block Drug Company, Inc. | 1979-10-09 |
| K772087 | ULTRASONIC DENTURE CLEANER | Clairol, Inc. | 1977-11-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810051088649 | GuruNanda Aligner and Denture Cleaning Foam | Gurunanda, LLC | 2026-04-29 |
| 00810194403972 | Aira | AIRA, LLC | 2026-01-16 |
| 00616784487724 | WeCare Denture Cleanser, Antibacterial | Dynarex Corporation | 2025-09-01 |
| 00855850008061 | Smilesaver | Soluria II LLC | 2024-06-19 |
| 00855850008078 | Smilesaver | Soluria II LLC | 2024-06-19 |
| 00855850008092 | Guard Health | Soluria II LLC | 2024-06-19 |
| 00855850008108 | Smilesaver | Soluria II LLC | 2024-06-19 |
| D832200451 | Plasdent | PLASDENT CORPORATION | 2023-05-31 |
| 06943566107391 | Y-Kelin | ANHUI GREENLAND BIOTECH CO.,LTD | 2022-12-06 |
| D784UZM30011 | Unipack | UNIPACK MEDICAL CORPORATION | 2022-12-06 |
| 06943566100118 | Y-Kelin | ANHUI GREENLAND BIOTECH CO.,LTD | 2022-12-06 |
| 00665973010885 | DawnMist | Dukal LLC | 2022-12-06 |
| 00665973010878 | DawnMist | Dukal LLC | 2022-12-06 |
| 00814832015879 | EFFERDENT ORIGINAL 102CT TAB 6 | Medtech Products Inc. | 2022-11-17 |
| 00814832015923 | EFFERDENT PM 90CT TAB 6 | Medtech Products Inc. | 2022-11-17 |
| 00814832015893 | EFFDNT PLUS MNT 44CT TAB 6 | Medtech Products Inc. | 2022-11-16 |
| 00814832015909 | EFFDNT PLUS MNT 90CT TAB 6 | Medtech Products Inc. | 2022-11-16 |
| 00814832015862 | EFFDNT ORIG 44CT TAB 6 | Medtech Products Inc. | 2022-11-16 |
| 00814832015930 | EFFDNT ORIG 252ct CLUB (2x126CT) TAB 12 | Medtech Products Inc. | 2022-09-28 |
| 00814832017354 | EFFDNT PM 126CT TAB 6 | Medtech Products Inc. | 2022-09-28 |
| 00814832015916 | EFFDNT PLUS MNT 126CT TAB 6 | Medtech Products Inc. | 2022-09-28 |
| 00814832015886 | EFFDNT ORIG 126CT TAB 6 | Medtech Products Inc. | 2022-09-28 |
| D8054505024 | TCS Fresh Concentrated Dental Appliance Cleaner | THERMOPLASTIC COMFORT SYS | 2021-03-30 |
| D8054505FRSMP6 | TCS Fresh Concentrated Dental Appliance Cleaner | THERMOPLASTIC COMFORT SYS | 2021-03-30 |
| D805OLA122 | Ola Fresh Dental Appliance Cleanser | THERMOPLASTIC COMFORT SYS | 2021-03-30 |
| D805OLA244 | Ola Fresh Dental Appliance Cleanser | THERMOPLASTIC COMFORT SYS | 2021-03-30 |
| 00085317003715 | Freshmint | NEW WORLD IMPORTS, INC. | 2020-08-11 |
| 00085317004309 | Freshmint | NEW WORLD IMPORTS, INC. | 2020-08-11 |
| 00818323023756 | Vive | VIVE HEALTH LLC | 2019-03-20 |
| D687821352FG2 | SmartPractice® Wares Tartar and Stain Remover | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |