FDA applicant
Kavo America
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
How often FDA has decided Kavo America’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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.
See the 510(k) ReportOther applicant names beginning “Kavo”
FDA records each applicant name separately; these may or may not be the same firm.