SmartMouth DryMouth Oral Rinse— 510(k) K181194

Substantially Equivalent

Triumph Pharmaceuticals, Inc.

FDA 510(k) clearance K181194 for SmartMouth DryMouth Oral Rinse, Substantially Equivalent on 2019-02-15. Applicant: Triumph Pharmaceuticals, Inc..

Clearance details

Applicant: Triumph Pharmaceuticals, Inc.
Product code: Code LFD
Advisory panel: Unknown
Date received: 2018-05-04
Decision date: 2019-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.