510(k) Report

FDA applicant

Tatung Company of America, Inc.

Long Beach, CA2 decisions1988–19880 recalls

FDA records 2 decisions for Tatung Company of America, Inc. (Long Beach, CA) in 1988: 2 510(k) clearances. Most are in product codes EFT (Cleanser, Denture, Over The Counter) and JER (Cleaner, Denture, Mechanical). No recall is linked to its devices.

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

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Tatung Company of America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tatung Company of America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tatung Company of America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EFTCleanser, Denture, Over The Counter1decision
  • JERCleaner, Denture, Mechanical1decision

What has FDA decided for it lately?

  • K881391Ultrasonic Denture CleanerTatung Company of America, Inc. · 1988
  • K874805Tatung's Denture Cleaning SolutionTatung Company of America, Inc. · 1988

All 2 as Tatung Company of America, Inc. →

Other applicant names beginning “Tatung”

FDA records each applicant name separately; these may or may not be the same firm.

Tatung Co. 1