Cleared Traditional

CloSYS? Dry Mouth Sensitive Mouth Rinse

K250390 · Rowpar Pharmaceuticals, Inc. · Dental

May 2025

Decision

97d

Days

—

Risk

About This 510(k) Submission

K250390 is an FDA 510(k) clearance for the CloSYS? Dry Mouth Sensitive Mouth Rinse, a Saliva, Artificial, submitted by Rowpar Pharmaceuticals, Inc. (Bridgewater, US). The FDA issued a Cleared decision on May 19, 2025, 97 days after receiving the submission on February 11, 2025. This device falls under the Dental review panel.

Submission Details

510(k) Number	K250390 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2025
Decision Date	May 19, 2025
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF