FDA applicant

Kaltenbach & Voigt GmbH

Biberach, DE11 decisions2008–20190 recalls

FDA records 11 decisions for Kaltenbach & Voigt GmbH (Biberach, DE) from 2008 to 2019: 11 510(k) clearances. Most are in product codes EFA (Handpiece, Belt And/Or Gear Driven, Dental) and EFB (Handpiece, Air-Powered, Dental). Its devices cite 18 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kaltenbach & Voigt GmbH & Co.”.

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 Kaltenbach & Voigt GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2008high 2 (2013) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Kaltenbach & Voigt GmbH by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kaltenbach & Voigt GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Kaltenbach”

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

Kaltenbach & Voigt Gmgh 1

Kaltenbach & Voigt GmbH

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 “Kaltenbach”