510(k) Report

510(k) · Cleared

Cleared

Ultrasonic Denture Cleaner

K881391510(k) TraditionalCleared Aug 26, 1988144-day reviewClass I21 CFR 872.3530

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. · JER Cleaner, Denture, Mechanical

Cleared on Aug 26, 1988 after a 144-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 26, 1988
Review
144 days
Class
Class I
Product code
JER
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K881391Source: 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.

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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 JER devices

JER Cleaner, Denture, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JER

FDA has decided no JER device since 2007.

Median 510(k) review, days · JER

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

Recalls per year · JER

No recall names JER since 2007.

Adverse event reports per year · JER

2in 2013

2007: 12011: 12013: 2
2007high 2 (2013) · low 0 (2008)2025

MAUDE reports naming product code JER, 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—01
20080—00
20090—00
20100—00
20110—01
20120—00
20130—02
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Tatung Company of America, Inc.

2 FDA decisions under this applicant name. See the company

  • K874805Tatung's Denture Cleaning SolutionTatung Company of America, Inc. · 1988

Recent decisions in JER

The JER category page

  • K883403Denta PlusConnoisseurs Products Corp. · 1988
  • K872521Denture CleansersDental Research Laboratories · 1987
  • K852906Duraclean Denture CleanerAstron Dental Corp. · 1985
  • K840805Oral SafeGreat Lakes Orthodontics, Ltd. · 1984
  • K832359Oral SafeGreat Lakes Orthodontics, Ltd. · 1983

https://510kreport.com/device/K881391 · printed Nov 4, 2026

Cite this page

510(k) Report. “K881391: Ultrasonic Denture Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K881391

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