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510(k) K250390

CloSYS® Dry Mouth Sensitive Mouth Rinse by Rowpar Pharmaceuticals, Inc. — Product Code LFD

K250390 is an FDA 510(k) premarket notification submitted by Rowpar Pharmaceuticals, Inc. for the device "CloSYS® Dry Mouth Sensitive Mouth Rinse". The FDA issued a decision of Substantially Equivalent on May 19, 2025. The device falls under product code LFD (Saliva, Artificial), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2025
Date Received
February 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saliva, Artificial
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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  • K234015 — Caphosol® Artifical Saliva (32 doses sachet box) (March 11, 2024)
  • K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray (August 22, 2023)
  • K202689 — Dentilube Spray (September 3, 2021)
  • K203567 — Oral-B Dry Mouth Oral Rinse (April 5, 2021)
  • K201277 — Oral-B Dry Mouth Oral Rinse (September 2, 2020)
  • K181839 — CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray (November 21, 2019)
  • K190144 — MucoPEG (November 5, 2019)
  • K181194 — SmartMouth DryMouth Oral Rinse (February 15, 2019)

FDA data resources