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BioXtra

Model 90077647 · ORABIO, INC. · DI 00850083135027

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

  • None linked in the loaded window.

Predicate lineage

K072306 — cited as predicate by K101346, K202689

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

Manufacturer compliance record — ORABIO, INC.

Nothing in the loaded window.