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

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..

Clearance details

Applicant: Oralabs, Inc.
Product code: Code LFD
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 ↗

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.