FDA applicant

Planmeca USA, Inc.

Finland, FI13 decisions1984–20110 recalls

FDA records 13 decisions for Planmeca USA, Inc. (Finland, FI) from 1984 to 2011: 13 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and KLC (Chair, Dental, With Operative Unit). Its devices cite 1 predicate, 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 Planmeca USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Planmeca”

FDA records each applicant name separately; these may or may not be the same firm.

Planmeca Oy 28

Planmeca USA, Inc.

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?

Other applicant names beginning “Planmeca”