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3M™ ESPE™

Model 12138 · 3M COMPANY · DI 30348878600030

LFD — Saliva, Artificial

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.

11222019-12: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device120910110104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1201
2020-0902
2020-1001
2020-1102
2021-0101
2026-0401
This device (reports/month)Average device in LFD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — 3M COMPANY

  • Warning Letter 2010-06-07 3M Company
  • NAI 2026-06-24 3m Company · 0 citations
  • NAI 2026-06-24 3m Company · 0 citations
  • VAI 2019-04-17 3M · 4 citations
  • NAI 2017-11-27 3M Company · 0 citations
  • NAI 2016-12-08 3M Company · 0 citations
  • NAI 2016-12-08 3M Company · 0 citations
  • NAI 2016-12-06 3M Company · 0 citations
  • NAI 2016-09-14 3M Company · 0 citations
  • VAI 2015-11-06 3M Company · 1 citations
  • OAI 2015-03-19 3m Canada Company · 5 citations
  • NAI 2014-07-09 3M Co · 0 citations
  • NAI 2014-07-09 3M Co · 0 citations
  • NAI 2014-06-26 3M Company · 0 citations
  • NAI 2014-06-26 3M Company · 0 citations
  • NAI 2014-04-25 3M Company · 0 citations
  • NAI 2013-12-13 3M Company · 0 citations
  • NAI 2013-08-16 3m Company · 0 citations
  • NAI 2013-08-16 3m Company · 0 citations
  • NAI 2013-03-28 3M Company · 1 citations
  • NAI 2012-12-05 3M COMPANY · 0 citations