FDA applicant

Inteware Co., Ltd.

Minxiong Township, Chiayi Country 62145, CN2 decisions2018–20190 recalls

FDA records 2 decisions for Inteware Co., Ltd. (Minxiong Township, Chiayi Country 62145, CN) from 2018 to 2019: 2 510(k) clearances. Most are in product codes PNN (Orthodontic Software) and LLZ (System, Image Processing, Radiological). 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 Inteware Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Inteware Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Inteware 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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Inteware Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?