FDA applicant

Ttbio Corp.

Taichung, TW6 decisions2014–20230 recalls

FDA records 6 decisions for Ttbio Corp. (Taichung, TW) from 2014 to 2023: 6 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and ELC (Scaler, Ultrasonic). Its devices cite 5 predicates, 1 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 Ttbio Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Ttbio Corp. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Ttbio Corp.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?