← Product Code LFD · K250390 # CloSYS® Dry Mouth Sensitive Mouth Rinse (K250390) _Rowpar Pharmaceuticals, Inc. · LFD · May 19, 2025 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K250390 ## Device Facts - **Applicant:** Rowpar Pharmaceuticals, Inc. - **Product Code:** LFD - **Decision Date:** May 19, 2025 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use Relieves the symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, and lubricates oral dryness. ## Device Story ClōSYS® Dry Mouth Sensitive Mouth Rinse is an over-the-counter oral rinse for home use; designed to alleviate xerostomia symptoms. The device is a ready-to-use, non-sterile, semi-viscous liquid containing water, humectants, moisturizers, flavors, and sweeteners. It functions by coating oral tissues to provide lubrication and moisture. The patient uses the rinse topically in the oral cavity to achieve relief from dryness and discomfort. No electronic, mechanical, or software components are involved. ## Clinical Evidence No clinical tests were performed. Evidence consists of bench-only testing, including biocompatibility assessments (Sensitization, Mucosal Irritation, Cytotoxicity) conducted per ISO 10993 and accelerated stability studies supporting a 2-year shelf life. ## Technological Characteristics Non-sterile, semi-viscous liquid oral rinse. Ingredients include water, glycerin (moisturizer), xylitol/sorbitol (sweeteners/humectants), and hydroxyethyl cellulose (thickener). pH balanced with citric acid. Packaged in 16 fl oz HDPE/PET bottles. No energy source, connectivity, or software. ## Predicate Devices - Biotène Dry Mouth Mouthwash & Biotène PBF Dry Mouth Mouthwash ([K123731](/device/K123731.md)) ## Reference Devices - Hydris™ Oral Rinse ([K163029](/device/K163029.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION May 19, 2025 Rowpar Pharmaceuticals Inc. % Steven Weisman Global President Innovative Science Solutions (D.B.A Lumanity) 10 N Park Place Suite 201 Morristown, New Jersey 07960 Re: K250390 Trade/Device Name: CloSYS® Dry Mouth Sensitive Mouth Rinse Regulatory Class: Unclassified Product Code: LFD Dated: February 3, 2025 Received: April 11, 2025 Dear Steven Weisman: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250390 - Steven Weisman Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K250390 - Steven Weisman Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, MICHAEL E. ADJODHA -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K250390 Device Name ClöSYS® Dry Mouth Sensitive Mouth Rinse Indications for Use (Describe) Relieves the symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, and lubricates oral dryness. Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} 510K Notification ClōSYS® Dry Mouth Sensitive Mouth Rinse Rowpar Pharmaceuticals, Inc. SECTION 5: 510(K) Summary K250390 1. APPLICANT INFORMATION Name: Rowpar Pharmaceuticals, Inc. Address: 440 US Highway 22, Suite 210 Bridgewater, NJ 08807 Contact Person: Michael Tune Telephone: +1 (901) -384-9070 Email ID: mtune@arcadiach.com Date Summary Prepared: 06 May 2025 2. SUBMITTER INFORMATION Name: Innovative Science Solutions (D.B.A Lumanity) Address: 10 N Park Place Suite 201, Morristown NJ 07960 Contact Person: Steven M. Weisman Telephone: +1 (973) -816-1130 Email ID: Steven.Weisman@lumanity.com 3. DEVICE NAME Device Name: ClōSYS® Dry Mouth Sensitive Mouth Rinse Trade or Proprietary Name: ClōSYS® Dry Mouth Sensitive Mouth Rinse Common or Usual Name: Saliva, Artificial Classification Name (if known): Saliva, Artificial 4. IDENTIFICATION OF EQUIVALENCE GlaxoSmithKline Consumer Healthcare: Biotène Dry Mouth Mouthwash & Biotène PBF Dry Mouth Mouthwash cleared in K123731 – Predicate Device. Biopharm Consults LLC: Hydris™ Oral Rinse cleared in K163029 – Reference Device 5. DEVICE DESCRIPTION ClōSYS® Dry Mouth Sensitive Mouth Rinse is an oral rinse designed to alleviate the symptoms of dry mouth for home use. The formulation includes water, humectants/ moisturizers, flavors, {5} 510K Notification ClöSYS® Dry Mouth Sensitive Mouth Rinse Rowpar Pharmaceuticals, Inc. sweeteners, as well as ingredients with lubricating, soothing, and refreshing properties. The product is a ready-to-use, non-sterile, semi-viscous clear liquid, packaged in 16.0 FL OZ white High-Density Polyethylene (HDPE) bottles within a carton. Accelerated stability testing of the finished product supports a shelf life of 2 years. The rinse is formulated to have similar properties as predicate product Biotene Dry Mouth Oral Rinse Fresh Mint, which is a medical device 510(k) Number K123731 and the reference device Hydris™ Oral Rinse cleared under K163029. ClöSYS® Dry Mouth Sensitive Mouth Rinse will be available in 16 fl oz (473 mL) PET bottles in a carton. ## 6. STATEMENT OF INDICATIONS FOR USE Relieves the symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, and lubricates oral dryness. ## 7. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS {6} 510K Notification ClöSYS® Dry Mouth Sensitive Mouth Rinse Rowpar Pharmaceuticals, Inc. | Attribute | ClöSYS® Dry Mouth Sensitive Mouth Rinse (Subject Device) | Biotène Dry Mouth Mouthwash & Biotène PBF Dry Mouth Mouthwash K123731 (Predicate) | Hydrist™ Oral Rinse K163029 (Reference) | | --- | --- | --- | --- | | Product Code/Panel | LFD/Dental | LFD/Dental | LFD/Dental | | Indications for Use | Relieves the symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, and lubricates oral dryness. | Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness | Relieves the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation and lubricate oral dryness. | | Method of Use | Ready to use liquid | Ready to use liquid | Ready to use liquid | | Applications Per Day | Up to 5 times a day | Up to 5 times a day | Up to 2 times a day | | Dosage (Per Use) | 15 mL | 15 mL | 20 mL | | Disease State | Xerostomia | Xerostomia | Xerostomia | | Presentation | Non-Sterile | Non-Sterile | Non-Sterile | | Environment of Use | Household | Household | Household | | Solvent | Water | Water | Water | | Moisturizers | Glycerin | Glycerin, Propylene Glycol | Glycerin, Propylene Glycol | | Sweetener/Humectants | Xylitol, Sorbitol | Xylitol, Sorbitol | Xylitol, Sorbitol | | Thickeners | Hydroxyethyl Cellulose | Hydroxyethyl Cellulose | Cellulose Gum, Xanthan Gum, Carbomer | | pH Buffers | Citric Acid | Disodium Phosphate, Sodium Phosphate | Disodium Phosphate, Sodium Phosphate | 3 {7} 510K Notification ClöSYS® Dry Mouth Sensitive Mouth Rinse Rowpar Pharmaceuticals, Inc. # 8. DISCUSSION OF DIFFERENCES There are certain differences between the proposed device and its predicate devices, specifically in the formulation of ClöSYS® Dry Mouth Sensitive Mouth Rinse. The variations in ingredients are primarily to ensure compatibility with the formula and flavor and for achieving desired stability. However, these modifications do not impact the safety profile of the product. The other variations in the formula/composition involve differences in the concentration and volume of common ingredients to ensure proper dispensing and use of the product. These changes do not affect the function, indications, or equivalency of the proposed product. In summary, the differences in formulation compared to the predicate devices do not alter the function, indications, efficacy, or substantial equivalency of the products. # 9. DISCUSSION AND CONCLUSIONS FROM THE NONCLINICAL AND CLINICAL TESTS ClöSYS® Dry Mouth Sensitive Mouth Rinse has been shown in non-clinical studies to be safe (Biocompatibility Assessments) and stable (Stability Studies) for its intended use. The standard biocompatibility testing such as Sensitization, Mucosal Irritation and Cytotoxicity was conducted using the subject device's finished final form. The testing was conducted in accordance with ISO 10993 Biological Evaluation of Medical Devices, as recognized by the FDA. The assays demonstrated an acceptable biocompatibility profile consistent with the predicate. Stability of the finished product is monitored at room temperature and under accelerated conditions. No other clinical tests were performed. ClöSYS® Dry Mouth Sensitive Mouth Rinse has the same intended use and the same technology as that of the legally marketed predicate device, Biotene® Dry Mouth Oral Rinse® and reference device Hydris™ Oral Rinse. This is demonstrated by comparing the proposed device and predicate devices indications for use, technological characteristics and performance data. Results from the biocompatibility assessment and performance testing further demonstrate substantial equivalence. This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807. --- **Source:** [https://fda.innolitics.com/device/K250390](https://fda.innolitics.com/device/K250390) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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