510(k) Report

510(k) · Cleared

Cleared

Tatung's Denture Cleaning Solution

K874805510(k) TraditionalCleared Feb 16, 198885-day reviewClass I21 CFR 872.3520

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tatung Company of America, Inc. · EFT Cleanser, Denture, Over The Counter

Cleared on Feb 16, 1988 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 16, 1988
Review
85 days
Class
Class I
Product code
EFT
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K874805Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All EFT devices

EFT Cleanser, Denture, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFT

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFT

Too few EFT 510(k)s in any year since 2007 to give a median.

Recalls per year · EFT

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EFT

11in 2025

2007: 92008: 122009: 172010: 122011: 252012: 182013: 312014: 132015: 202016: 672017: 832018: 792019: 552020: 682021: 742022: 402023: 442024: 422025: 11
2007high 83 (2017) · low 9 (2007)2025

MAUDE reports naming product code EFT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—09
20081—012
20090—017
20100—012
20110—025
20120—018
20130—031
20140—013
20150—020
20160—067
20170—083
20180—079
20190—055
20200—068
20210—074
20220—040
20230—144
20240—042
20250—011
20260—0—

More from Tatung Company of America, Inc.

2 FDA decisions under this applicant name. See the company

  • K881391Ultrasonic Denture CleanerTatung Company of America, Inc. · 1988

Recent decisions in EFT

The EFT category page

  • K080631Cleanse.Freshen.GO; Aligner Cleansing Towelette and Dental Appliance CleanserOral Health Technologies, LLC · 2008
  • K051342Medical InterporousBonyf AG · 2006
  • K000996Trubyte Denture Cleanser/Polishing CompoundDentsply Intl. · 2000
  • K942203Otc Denture CleanserCombe, Inc. · 1994
  • K930337Profast (R)-Denture CleanserFittydent-Altwirth & Schmitt GmbH · 1993

https://510kreport.com/device/K874805 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874805: Tatung's Denture Cleaning Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874805

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026