AIOBIO
Model LINKDENS QC · AIOBIO CO.,LTD · DI 08800043200090
NBL — Light-Induced Fluorescence Caries Detector · Class II · 21 CFR 872.1745
UDILibrary device dossier · generated 2026-09-12 · 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
- K221275 SESE 2024-09-04 (k number procode)
Predicate lineage
K221275 — cites (transitively): K040063 (d1)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — AIOBIO CO.,LTD
Nothing in the loaded window.