GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray— 510(k) K181134

Substantially Equivalent

Sunstar Americas, Inc.

FDA 510(k) clearance K181134 for GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray, Substantially Equivalent on 2018-07-13. Applicant: Sunstar Americas, Inc..

Clearance details

Applicant: Sunstar Americas, Inc.
Product code: Code LFD
Advisory panel: Unknown
Date received: 2018-04-30
Decision date: 2018-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, 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.