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THERABREATH LOZENGE

Model 00697029241127 · CHURCH & DWIGHT CO., INC. · DI 00697029241127

LFD — Saliva, Artificial

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.

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

  • K171542 SESE 2018-03-16 (k number procode)

Predicate lineage

K171542 — cites (transitively): K023046 (d1), K111250 (d1), K152201 (d1), K101477 (d2), K061331 (d2), K101346 (d2), K123731 (d2), K070854 (d3), K072306 (d3)

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

Manufacturer compliance record — CHURCH & DWIGHT CO., INC.

  • Warning Letter 2011-05-16 Church & Dwight Inc
  • Warning Letter 2011-05-16 Church & Dwight Inc
  • NAI 2024-08-12 Church & Dwight Manufacturing Co., Ltd. · 0 citations
  • NAI 2024-07-18 Church & Dwight Canada Corp. · 0 citations
  • NAI 2023-08-08 Church & Dwight Manufacturing Co., Ltd. · 0 citations
  • NAI 2022-07-15 Church & Dwight Manufacturing Co., Ltd. · 0 citations
  • NAI 2020-08-14 Church & Dwight Inc · 0 citations
  • NAI 2020-08-14 Church & Dwight Inc · 0 citations
  • VAI 2017-10-31 Church & Dwight Manufacturing Co., Ltd. · 1 citations
  • NAI 2015-08-06 Church & Dwight Inc · 0 citations
  • NAI 2015-08-06 Church & Dwight Inc · 0 citations
  • VAI 2015-03-13 Church & Dwight Manufacturing Co., Ltd. · 2 citations
  • VAI 2012-08-24 Church & Dwight Manufacturing Co., Ltd. · 2 citations
  • VAI 2012-02-13 Church & Dwight Inc · 5 citations
  • VAI 2012-02-13 Church & Dwight Inc · 5 citations
  • NAI 2011-02-17 Church & Dwight Co., Inc. · 0 citations
  • OAI 2011-02-17 Church & Dwight Inc · 7 citations
  • OAI 2011-02-17 Church & Dwight Inc · 7 citations
  • VAI 2010-07-08 Church & Dwight Manufacturing Co., Ltd. · 3 citations