Cleared Traditional

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

K250390 · Rowpar Pharmaceuticals, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
97d
Days
-
Risk

K250390 is an FDA 510(k) clearance for the CloSYS® Dry Mouth Sensitive Mouth Rinse. Classified as Saliva, Artificial (product code LFD).

Submitted by Rowpar Pharmaceuticals, Inc. (Bridgewater, US). The FDA issued a Cleared decision on May 19, 2025 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Rowpar Pharmaceuticals, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Consultant

Innovative Science Solutions (D.B.A Lumanity)
Steven Weisman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFD Saliva, Artificial

All 49
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K250390.
Allday Moisturizing Rinse
K253778 · Elevate Oral Care · Feb 2026
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K240508 · Laclede, Inc. · Apr 2024
Caphosol® Artifical Saliva (32 doses sachet box)
K234015 · Eusa Pharma (Uk) Limited · Mar 2024
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205 · Gurunanda, LLC · Aug 2023
Dentilube Spray
K202689 · Oxy2plus, LLC · Sep 2021
Oral-B Dry Mouth Oral Rinse
K203567 · The Procter & Gamble Company · Apr 2021