FDA applicant

Dunia Perwira Manufacturing Sdn. Bhd.

Upm Serdang, Selangor, MY1 decision2005–20050 recalls

FDA records 1 decision for Dunia Perwira Manufacturing Sdn. Bhd. (Upm Serdang, Selangor, MY) in 2005: 1 510(k) clearance. All are in product code EJJ (Alloy, Amalgam). 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 Dunia Perwira Manufacturing Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dunia Perwira Manufacturing Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dunia Perwira Manufacturing Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dunia Perwira Manufacturing Sdn. Bhd.’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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Dunia Perwira Manufacturing Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?