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

JT-3D

Model NR 16 Channel · Bio-Research Associates, Inc. · DI 00860003499917

NFS — Device, Jaw Tracking, For Monitoring Jaw Positions · Class I · 21 CFR 872.2060

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

  • None linked in the loaded window.

Manufacturer compliance record — Bio-Research Associates, Inc.

  • VAI 2018-03-21 Bio-Research Associates Inc. · 3 citations
  • NAI 2015-04-23 Bio-Research Associates Inc. · 0 citations