Atlas FDA

EFT

26 FDA 510(k) clearances · Product code

80 daysmedian time to decision
228 days90th percentile
26clearances measured

FDA profile

Official device name
Cleanser, Denture, Over The Counter
Device class
Class I (low risk)
Regulation
21 CFR 872.3520
Medical specialty
Dental
Adverse events (MAUDE)
2019: 55 · 2020: 68 · 2021: 74 · 2022: 40 · 2023: 44 · 2024: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER (K080631)Oral Health Technologies, LLC2008-05-23
MEDICAL INTERPOROUS (K051342)Bonyf AG2006-06-02
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND (K000996)Dentsply Intl.2000-06-16
OTC DENTURE CLEANSER (K942203)Combe, Inc.1994-08-10
PROFAST(R)-DENTURE CLEANSER (K930337)Fittydent-Altwirth & Schmitt GmbH1993-09-07
DENTURE PRODUCT X (K914257)Essential Dental Systems, Inc.1993-01-13
CFR MONOGRAPH (K925259)Combe, Inc.1993-01-11
DENTURE DYNAMIC'S DENTURE MAGIC (K902838)Denture Dynamic'S, Inc.1990-09-06
ARGILITE 4 GOLD ALLOY FOR PORCELAIN (K903686)Argen Precious Metals, Inc.1990-08-29
ORAD TOOTHBRUSH CLEANER (K895345)Orad, Inc.1990-03-07
DENTCLEAN CONCENTRATED DENTURE CLEANSER (K890043)K-P Co.1989-06-07
CLEAN DENT (K890668)Lincoln Park Dental Laboratory1989-04-17
EFFERVESCENT DENTURE CLEANSER (K880068)Perrigo Co.1988-03-07
TATUNG'S DENTURE CLEANING SOLUTION (K874805)Tatung Company of America, Inc.1988-02-16
DENTURE CLEANSING TABLET (K871785)Pennex Products Co., Inc.1987-09-11
DENCLENZ (K854995)Creighton Products Corp.1986-05-12
SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 (K860118)Northern Electric Co. Div. of Sunbeam Corp.1986-04-17
TEEN CLEAN, RETAINER CLEANER (K860737)Teen Care, Inc.1986-03-26
PEPSODENT DENTURE CLEANSER PDP FORMULA (K851183)Lever Brothers Company, Inc.1985-04-29
PEPSODENT DENTURE CLEANSER-WESTONE FORMULA (K851182)Lever Brothers Company, Inc.1985-04-29
PRE-KLENE ENAMEL CLEANER (K844572)Medical Products Laboratories, Inc.1985-01-18
DENTURE CLEANSER (K841801)Miracle Clean, Inc.1984-06-22
SPRYCE, DENTURE CLEANSER (K820020)Richardson-Vicks, Inc.1982-01-22
DENTURE CLEANER (K810279)Mcdennan Oral Products, Inc.1981-02-23
DUO TWO LAYER DENTURE CLEANSER (K791064)Block Drug Company, Inc.1979-10-09
ULTRASONIC DENTURE CLEANER (K772087)Clairol, Inc.1977-11-14

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Every clearance here is in the API, with alerts when new ones post.