DRY MOUTH MOUTHWASH— 510(k) K111250

Substantially Equivalent

Dr. Fresh, Inc.

FDA 510(k) clearance K111250 for DRY MOUTH MOUTHWASH, Substantially Equivalent on 2012-04-27. Applicant: Dr. Fresh, Inc..

Clearance details

Applicant: Dr. Fresh, Inc.
Product code: Code LFD
Advisory panel: Unknown
Date received: 2011-05-04
Decision date: 2012-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, VA, 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.