FDA applicant

Hallim Dentech Co., Ltd.

Fullerton, CA1 decision2011–20110 recalls

FDA records 1 decision for Hallim Dentech Co., Ltd. (Fullerton, CA) in 2011: 1 510(k) clearance. All are in product code EIA (Unit, Operative Dental). 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 Hallim Dentech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Hallim Dentech Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Hallim Dentech Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?