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GC Tri Plaque ID Gel™

Model 004273 · Gc America Inc. · DI D0470042731

NYH — Plaque Disclosing Kit · Class II · 21 CFR 872.1740

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.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Gc America Inc.

  • Warning Letter 2012-11-21 GC America, Inc.
  • Warning Letter 2012-11-21 GC America, Inc.
  • VAI 2019-03-28 GC America, Inc. · 6 citations
  • VAI 2019-03-28 GC America, Inc. · 6 citations
  • OAI 2015-10-26 GC America, Inc. · 0 citations
  • OAI 2015-10-26 GC America, Inc. · 0 citations
  • NAI 2014-07-25 GC Asahi Corporation · 0 citations
  • NAI 2014-06-06 GC America, Inc. · 0 citations
  • NAI 2014-06-06 GC America, Inc. · 0 citations
  • VAI 2013-06-13 GC America, Inc. · 0 citations
  • VAI 2013-06-13 GC America, Inc. · 0 citations
  • VAI 2013-02-05 GC Europe N.V. · 1 citations
  • OAI 2012-07-13 GC America, Inc. · 0 citations
  • OAI 2012-07-13 GC America, Inc. · 0 citations
  • NAI 2010-02-08 GC America, Inc. · 0 citations
  • NAI 2010-02-08 GC America, Inc. · 0 citations