510(k) Report

FDA applicant

Kavo America

Lake Zurich, IL24 decisions1991–20081 recall

FDA records 24 decisions for Kavo America (Lake Zurich, IL) from 1991 to 2008: 23 510(k) clearances and 1 De Novo grant. Most are in product codes GEX (Powered Laser Surgical Instrument) and NBL (Light-Induced Fluorescence Caries Detector). Its devices cite 24 predicates, 12 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Kavo America Corporation”.

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 Kavo America’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 22008: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kavo America’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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Other applicant names beginning “Kavo”

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