Cleanser, Denture, Over The Counter
Dental · 21 CFR 872.3520
Recent MDR events
776 adverse event reports on file
- RETAINER BRITE CLEANING TABLETS -96 CT KITJun 3, 2025InjuryDentsply Sirona Orthodontics Inc.1036212-2025-00001
- POLIDENTMay 7, 2025Injury1314819-2025-00091
- POLIDENTApr 24, 2025Injury1314819-2025-00085
- COREGAApr 24, 2025Injury1314819-2025-00086
- INVISALIGN CLEANING CRYSTALSApr 3, 2025MalfunctionAlign Technology, Inc.2953749-2025-00650
- INVISALIGN CLEANING CRYSTALSApr 1, 2025InjuryAlign Technology, Inc.2953749-2025-00621
- COREGA BIO-ACTIVE OXYGENMar 11, 2025Injury1314819-2025-00048
- POLIDENT PRO GUARD & RETAINERJan 24, 2025Injury1314819-2025-00005
- COREGA TOTAL ACTIONJan 23, 2025Injury1314819-2025-00006
- COREGA BIOJan 22, 2025Injury1314819-2025-00004
Event type breakdown
Recalls
3 recall events for this product code
- Family Dollar Stores, Llc.Open, ClassifiedNov 7, 2023
GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312
Products were stored outside of labeled temperature requirements.
Z-0267-2024 · View FDA record ↗ - Family Dollar Stores, Llc.Open, ClassifiedAug 17, 2022
GS DENTURE CLEANSER GRN TAB 40CT, SKU 906312
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1534-2022 · View FDA record ↗ - Family Dollar Stores, Llc.Open, ClassifiedAug 17, 2022
POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1544-2022 · View FDA record ↗
Registered firms
131 firms currently registered for this product code
Vive Health Llc
Naples, FL, US
Jiangxi Ivismile Technology Co.,ltd
Yichun City Jiangxi, CN
Andpak, Inc.
Morgan Hill, CA, US
Plasdent Shanghai Co., Ltd.
Shanghai, CN
The Procter & Gamble Distributing Llc
Morris, IL, US
Jiaoyue Pharmaceutical (huizhou) Co.ltd
Huizhou Guangdong, CN
Erskine Dental
MACKSVILLE New South Wales, AU
Microcare Medical
Commerce City, CO, US
Havpak, Inc.
Malvern, PA, US
Oketz Logistics Llc
Coral Gables, FL, US
Perma Laboratories
Hinckley, OH, US
Wsd Labs Usa Inc
Tonawanda, NY, US
Tower Laboratories, Ltd.
Centerbrook, CT, US
Cory Labs
Alsip, IL, US
Novalab Inc.
DRUMMONDVILLE Quebec, CA
Cangzhou Lankang Medical Instruments Developing Co., Ltd.
Cangzhou Hebei, CN
Haleon Us Holdings Llc
Warren, NJ, US
Accupac, Llc
MAINLAND, PA, US
Javid De Mexico S. De R.l. De C.v. (resplabs)
Nogales Sonora, MX
Westrock Converting, Llc
Winston Salem, NC, US
Daiso Industries Co., Ltd.
Higashihiroshima, JP
Worldwide Supplies Limited
Hong Kong, HK
Somnomed Inc.
Plano, TX, US
Haleon Us Inc.
Lincoln, NE, US
Ekong Technology Co., Limited.
Shenzhen Guangdong, CN
510(k) clearances
26 clearances for this product code
- Oral Health Technologies, LLCMay 23, 2008
K080631 · CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER
- Bonyf AGJun 2, 2006
K051342 · MEDICAL INTERPOROUS
- Dentsply Intl.Jun 16, 2000
K000996 · TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
- Combe, Inc.Aug 10, 1994
K942203 · OTC DENTURE CLEANSER
- Fittydent-Altwirth & Schmitt GmbHSep 7, 1993
K930337 · PROFAST(R)-DENTURE CLEANSER
- Essential Dental Systems, Inc.Jan 13, 1993
K914257 · DENTURE PRODUCT X
- Combe, Inc.Jan 11, 1993
K925259 · CFR MONOGRAPH
- Denture Dynamic'S, Inc.Sep 6, 1990
K902838 · DENTURE DYNAMIC'S DENTURE MAGIC