Cleared Traditional

K250390 - CloSYS® Dry Mouth Sensitive Mouth Rinse (FDA 510(k) Clearance)

K250390 · Rowpar Pharmaceuticals, Inc. · Dental device
May 2025
Decision
97d
Days
-
Risk

K250390 is an FDA 510(k) clearance for the CloSYS® Dry Mouth Sensitive Mouth Rinse. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number K250390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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

Device Classification

Product Code LFD - Saliva, Artificial
Device Class -