Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

DIAGNOdent 2095 perio tip

Model 1.004.1640 · KaVo Dental GmbH · DI EKAV100416400

NBL — Light-Induced Fluorescence Caries Detector · Class II · 21 CFR 872.1745

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — KaVo Dental GmbH

  • NAI 2013-02-07 Kaltenbach & Voigt Dental Gmbh · 0 citations