FDA applicant

Bonart Co., Ltd.

Walnut, CA14 decisions2000–20170 recalls

FDA records 14 decisions for Bonart Co., Ltd. (Walnut, CA) from 2000 to 2017: 14 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and EBZ (Activator, Ultraviolet, For Polymerization). Its devices cite 4 predicates, 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 Bonart Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Bonart Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?