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DOA Kit, 5D Plus

Model 212269 · Align Technology, Inc. · DI 00816063021087

NTK — Light Transmission Caries Detector · Class II · 21 CFR 872.1745

UDILibrary device dossier · generated 2026-09-13 · 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.

12232023-08: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 3/device2025-07: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 2/device08100709
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0802
2023-1003
2025-0701
2025-0902
This device (reports/month)Average device in NTK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K193659 — cites (transitively): K172007 (d1), K043068 (d2), K071429 (d2), K090169 (d2), K123402 (d2), K132953 (d2) — cited as predicate by K240573

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Align Technology, Inc.

  • Warning Letter 2010-11-17 Align Technology Inc
  • Warning Letter 2010-11-17 Align Technology Inc
  • NAI 2015-06-02 Align Technology Inc · 0 citations
  • NAI 2015-06-02 Align Technology Inc · 0 citations
  • NAI 2011-12-23 Align Technology Inc · 0 citations
  • NAI 2011-12-23 Align Technology Inc · 0 citations
  • OAI 2010-08-09 Align Technology Inc · 2 citations
  • OAI 2010-08-09 Align Technology Inc · 2 citations