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Allday GEL

Model 626GEL110 · ELEVATE ORAL CARE, LLC · DI 00858290006710

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

  • K150074 SESE 2015-06-19 (k number procode)

Predicate lineage

K150074 — cites (transitively): K101346 (d1), K123731 (d1), K061331 (d2), K070854 (d2), K072306 (d2) — cited as predicate by K253778

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

Manufacturer compliance record — ELEVATE ORAL CARE, LLC

  • NAI 2025-05-15 Elevate Oral Care · 0 citations
  • NAI 2025-05-15 Elevate Oral Care · 0 citations
  • NAI 2023-09-07 Elevate Oral Care · 0 citations
  • NAI 2023-09-07 Elevate Oral Care · 0 citations
  • VAI 2015-08-28 Elevate Oral Care · 8 citations
  • VAI 2015-08-28 Elevate Oral Care · 8 citations