510(k) Report

FDA applicant

Jindell Medical Instruments Co., Ltd.

Hsin-Chu City, TW1 decision2006–20060 recalls

FDA records 1 decision for Jindell Medical Instruments Co., Ltd. (Hsin-Chu City, TW) in 2006: 1 510(k) clearance. All are in product code EFB (Handpiece, Air-Powered, Dental). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Jindell Medical Instruments Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jindell Medical Instruments Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Jindell Medical Instruments Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jindell Medical Instruments Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EFBHandpiece, Air-Powered, Dental1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062740Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 20064cite it

What has FDA decided for it lately?

  • K062740Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006

The one decision as Jindell Medical Instruments Co., Ltd. →