← Product Code LFD · K181134 # G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray (K181134) _Sunstar Americas, Inc. · LFD · Jul 13, 2018 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K181134 ## Device Facts - **Applicant:** Sunstar Americas, Inc. - **Product Code:** LFD - **Decision Date:** Jul 13, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use G+U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G•U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G.U.M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. ## Device Story Artificial saliva formulations (gel, rinse, spray) designed to manage dry mouth symptoms; contain water, humectants, sweeteners, and flavors. Applied topically to oral mucosa by patient at home. Lubricates, moisturizes, and soothes oral tissue; provides symptomatic relief. No complex processing or electronic components; functions via chemical/physical properties of ingredients. ## Clinical Evidence Bench testing only. Comparison of technological characteristics (pH, viscosity, specific gravity) between subject and predicate devices. Biocompatibility testing performed in conformance with ISO 10993-1. Biological Risk Assessment conducted by NAMSA. ## Technological Characteristics Artificial saliva formulation; pH 5.5-7.0. Ingredients: water, humectants, sweeteners, flavors, preservatives. Gel in polyethylene laminate tube; rinse/spray in PET bottles with polypropylene caps. Ready-to-use, non-sterile, over-the-counter. No electronic or software components. ## Predicate Devices - Biotene® Oral Balance® Dry Mouth Moisturizing Gel and Biotene Dry Mouth Oral Rinse and Biotene Dry Mouth Spray ([K123731](/device/K123731.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a symbol with three stylized human figures. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are placed side by side. July 13, 2018 Sunstar Americas Inc Ms. Liz Bastian Regulatory Affairs Manager 301 E. Central Road Schaumburg, Illinois 60195 Re: K181134 Trade/Device Name: GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray Regulatory Class: Unclassified Product Code: LFD Dated: April 27, 2018 Received: April 30, 2018 Dear Liz Bastian: 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 (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. 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ K181134 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ## Mary S. Runner -S forTina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181134 Device Name G•U•M® HYDRAL™ Dry Mouth Oral Gel G•U•M® HYDRAL™ Dry Mouth Oral Rinse G.U.M® HYDRAL™ Dry Mouth Oral Spray Indications for Use (Describe) G+U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G+U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G-U·M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ### 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." {3}------------------------------------------------ #### 510(k) Summary | Manufacturer Name: | Sunstar Americas, Inc. | |--------------------------|------------------------------------------------------------------------------------------------------------| | Address: | 301 E. Central Rd.
Schaumburg, IL | | Contact Name: | Liz Bastian | | Title: | Regulatory Affairs Manager | | Phone Number: | 847 794 4231 | | Date Prepared: | July 12, 2018 | | Device Proprietary Name: | G•U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse G•U•M® HYDRAL™ Dry Mouth Oral Spray | | Common or Usual Name: | Artificial Saliva | | Classification Name: | Saliva, Artificial | | Classification Code: | LFD | | Regulation Number: | Unclassified | ### Predicate Device: Biotene® Oral Balance® Dry Mouth Moisturizing Gel and Biotene Dry Mouth Oral Rinse and Biotene Dry Mouth Spray, K123731. Dental Devices Panel Unclassified ### Description of the Device Device Classification Review Panel G+U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse and G•U•M® HYDRAL™ Dry Mouth Oral Spray are specifically formulated artificial saliva with a pH between 5.00 to 7.00. The proposed device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, soothing, and humectant, sweeteners and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth. The device is provided in a realy to use at home. G-U-M- HYDRAL" " Dry Mouth Oral Gel is supplied in a 1.5-oune Polyethylene Laminate tube. G-U-M " Hrise is spay i.69 fluid ounce bottle. Both rinse and spray are packaged in Polyethylene Terephthalate (PET) bottles with white polypropylene caps. {4}------------------------------------------------ K181134 G•U•M® HYDRAL™ Dry Mouth Oral Gel G•U•M® HYDRAL™ Dry Mouth Oral Rinse G•U•M® HYDRAL™ Dry Mouth Oral Spray ### Intended Use/Indications for Use G+U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G•U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G.U.M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness ### Indications for Use Discussion The intended use statements of the GrUpM® HYDRAL™ Dry Mouth Oral Gel, G-U•M® HYDRAL™ Dry Mouth Oral Rinse and G+U•M® HYDRAL™ Dry Mouth Oral Spray are the same as the predicate devices; hence there are no differences in the intended therapeutic use of the device, both the subject and predicate devices are intended to relieve and manage symptoms of dry mouth. ### Technological Characteristics G+U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse and G•U•M® HYDRAL™ Dry Mouth Oral Spray are intended for over the counter use and are provided ready to use. The predicate and the proposed devices use the same fundamental technology. The mode of action of G-J-M® HYDRAL™ Dry Mouth Oral Gel, G-U·M® HYDRAL™ Dry Mouth Oral Rinse and G+U•M® HYDRAL™ Dry Mouth Oral Spray are substantially equivalent to that of the predicate devices (Biotene®) Oral Balance® Dry Mouth Moisturizing Gel and Biotene Dry Mouth Oral Rinse and Biotene Dry Mouth Spray, K123731). Both the proposed and predicate devices contain ingredients such as water, humectants/moisturizers, sweeteners, flavors and preservatives. The proposed and predicate devices are also similar in design and packaging. Below is a summary of the technological characteristics compared to the primary predicate device: {5}------------------------------------------------ Sunstar Americas, Inc. K181134 G-U-M® HYDRAL™ Dry Mouth Oral Gel, G+U-M® HYDRAL™ Dry Mouth Oral Rinse, G+U+M® HYDRAL™ Dry Mouth Oral Spray # Table 1: Comparison of Technological Characteristics | Parameter | G•U•M® HYDRAL™ | Biotene® K123731 | |------------------|---------------------------|---------------------------| | Gel | | | | Appearance | Clear, translucent gel | clear, transparent gel | | Color | Colorless to Pale Yellow | clear, colorless | | Odor | slight mint odor | odorless | | pH | 5.5 to 7.0 | 5.5 to 7.0 | | Viscosity | 120,000 cps | 146,600 cps | | Specific Gravity | 1.11 | 1.18 | | Rinse | | | | Appearance | clear, transparent liquid | clear, transparent liquid | | Color | clear, colorless | clear, colorless | | Odor | slight mint odor | spearmint odor | | pH | 5.5 to 7.0 | 5.5 to 7.0 | | Viscosity | 20.39 Sct | 10.26 Sct | | Specific Gravity | 1.06 | 1.08 | | Spray | | | | Appearance | clear, transparent liquid | clear, transparent liquid | | Color | clear, colorless | clear, colorless | | Odor | slight mint odor | spearmint odor | | pH | 5.5 to 7.0 | 5.5 to 7.0 | | Specific Gravity | 1.06 | 1.10 | {6}------------------------------------------------ Sunstar Americas, Inc. K181134 #### Discussion of differences G•U•M® HYDRAL Dry Mouth Oral Gel G•U•M® HYDRAL Dry Mouth Oral Rinse G•U•M® HYDRAL Dry Mouth Oral Spray The formulations for the submission devices differ from those of the predicate device; however, many of the submission device components have been cleared for use in previously FDA cleared devices with the same or highly similar indications for use. The variations in the formula / composition do not affect the functions or equivalency of the proposed products, they are primarily related to viscosity control and flavor. In summary, these differences in formulation to the predicate devices do not alter the functions, or substantial equivalency of the products. Any new components/ingredients are designated as GRAS ingredients, food additives or have a significant history of use in dental and medical or food applications. All components of the product have been manufactured and tested using standardized and industry accepted state of the art production/test methods. The finished products have been tested using standardized and industry accepted test methods. Additionally, we commissioned a Biological Risk Assessment of the ingredients performed by NAMSA and the results do not raise any safety questions. The report begins on page 431 and ends on page 464. ## Performance Data The following nonclinical data are included in the submission in substantial equivalence determination: - 0 Bench testing comparing predicate and proposed devices' technological characteristics was performed. It was demonstrated that predicate and proposed devices are not significantly different from each other in terms of technological characteristics. - Shelf life Stability Report - Biocompatibility testing in conformance with 10993-1. #### Conclusion Based upon the similarity of the intended use and fundamental technology, together with non-performance testing, GUM Hydral is substantially equivalent to K123731. --- **Source:** [https://fda.innolitics.com/device/K181134](https://fda.innolitics.com/device/K181134) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com