510(k) Report

FDA applicant

Shanghai Fimet Medical Instrument Co., Ltd.

Deer Field, IL1 decision2005–20050 recalls

FDA records 1 decision for Shanghai Fimet Medical Instrument Co., Ltd. (Deer Field, IL) in 2005: 1 510(k) clearance. All are in product code EIA (Unit, Operative 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 Shanghai Fimet Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Fimet Medical Instrument Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • EIAUnit, Operative 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 2 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.

  • K052470F1 Series Dental Chairs with Operative UnitShanghai Fimet Medical Instrument Co., Ltd. · 20052cite it

What has FDA decided for it lately?

  • K052470F1 Series Dental Chairs with Operative UnitShanghai Fimet Medical Instrument Co., Ltd. · 2005

The one decision as Shanghai Fimet Medical Instrument Co., Ltd. →