Cleared Traditional

K250390 - CloSYS Dry Mouth Sensitive Mouth Rinse

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

FDA 510(k) Submission Details - K250390

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.

LFD Device Classification - Class 0,

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 17
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