CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray— 510(k) K181839

Name: FDA 510(k) clearance K181839
Creator: U.S. Food and Drug Administration
Published: 2019-11-21

Substantially Equivalent

Oralabs, Inc.

FDA 510(k) clearance K181839 for CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray, Substantially Equivalent on 2019-11-21. Applicant: Oralabs, Inc.. Device class: Unclassified.

Clearance details

Applicant: Oralabs, Inc.
Product code: Code LFD
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-07-11
Decision date: 2019-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parker, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LFD

product code LFD

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.