GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray

K231205 · Gurunanda, LLC · LFD · Aug 22, 2023 · DE

Device Facts

• Record ID: K231205
• Device Name: GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
• Applicant: Gurunanda, LLC
• Product Code: LFD · DE
• Decision Date: Aug 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are intended to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.

Device Story

GuruNanda Dry Mouth Oral Rinse and Oral Spray function as artificial saliva substitutes. Formulated with water, moisturizers, humectants, sweeteners, and flavors; these agents provide lubricating, moisturizing, and refreshing properties to manage xerostomia symptoms. Intended for unsupervised consumer use; applied topically to the mouth as needed. The rinse and spray act by temporarily substituting the feel of natural saliva to diminish oral discomfort. No complex processing or electronic components involved; efficacy relies on chemical formulation.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, and irritation) was performed and passed in conformity with ISO 10993-5, ISO 10993-10, and ISO 10993-23.

Technological Characteristics

Artificial saliva substitute; liquid formulation containing water, moisturizers, humectants, sweeteners, and flavors. Biocompatibility tested per ISO 10993-5, ISO 10993-10, and ISO 10993-23. Non-sterile. Ready-to-use liquid form factor.

Indications for Use

Indicated for individuals experiencing symptoms of dry mouth (xerostomia) requiring relief, moisturization, and lubrication of the oral cavity.

Predicate Devices

• Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray (K123731)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 22, 2023

GuruNanda LLC Chetan Patel Director, Formulation Development and Regulatory Affairs 6645 Caballero Blvd. Buena Park, California 90620

Re: K231205

Trade/Device Name: GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray Regulatory Class: Unclassified Product Code: LFD Dated: April 27, 2023 Received: April 27, 2023

Dear Chetan Patel:

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. 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 located 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.

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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Bobak Shirmohammadi -5

For Michael E. Adjodha, M. ChE., 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

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

N/A

Device Name

GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray

Indications for Use (Describe)

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are intended to 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)

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Image /page/3/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are stacked on top of each other in a brown, cursive font. There is a curved line above the word "Nanda".

Caballero Blvd. Buena Park, CA 90620 | [phone] Office | www.GuruNanda.com

## K231205 - 510(k) Summary

#### 510(k) Owner:

Puneet Nanda GuruNanda LLC 6645 Caballero Blvd. Buena Park, CA 90620 Telephone: [phone] E-Mail: [e-mail]

#### Contact Person:

Chetan Patel GuruNanda LLC 6645 Caballero Blvd. Buena Park, CA 90620 Establishment Registration Number: 3014468707 Telephone:[phone] E-Mail: [e-mail]

Date: July 6, 2023

| Common/Usual Names: Common Name | Common / Classification Name |
|---------------------------------|------------------------------|
| Dry Mouth Oral Rinse | Saliva, Artificial |
| Dry Mouth Oral Spray | Saliva, Artificial |

Classification Name: Saliva, Artificial

Product Code: LFD

### Identification of a Legally Marketed Predicate Device:

Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray (K123731).

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Image /page/4/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are written in a brown, sans-serif font. There is a curved line above the word "Nanda". The "R" symbol is located at the bottom right of the logo.

LERO BLVD. BUENA PARK, CA 90620 | [phone] OFFICE | www.GURUNANDA.com

# General Description

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are specifically formulated as an artificial saliva substitute with water, moisturizers, humectants, sweeteners, and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth (xerostomia).

### Indications for Use:

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are intended to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.

## Indications for Use Discussion:

The only difference between the subject device (GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray) and the predicate device is in the name.

## Technological Characteristics

The proposed and predicate devices are similar in design and packaging. Any difference in the chemical compositions between the subject device and predicate device are minor and do not affect the safety and effectiveness.

# Substantial Equivalence Discussion

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are substantially equivalent to Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray (K123731) in intended use, design, materials, chemical composition, and performance.

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Image /page/5/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are stacked on top of each other in a brown, cursive font. There is a curved line above the word "Nanda" and a registered trademark symbol to the bottom right of the word.

## Substantial Equivalence Comparison

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are substantially equivalent to Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray (K123731) in intended use, design, materials, chemical composition, and performance.

An overview side-by-side comparison of the GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray, and Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray (K123731) as the predicate device is presented below.

| | Guru Nanda Dry Mouth Oral<br>Rinse and Oral Spray | Biotene Dry Mouth Oral Rinse and<br>Biotene Moisturizing Mouth<br>Spray (K123731) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K231205 | K123731 |
| Product Code | LFD | LFD |
| Device Common<br>Name | Saliva, Artificial | Saliva, Artificial |
| Device Trade Name | GuruNanda Private Label<br>Dry Mouth Oral Rinse and<br>Oral Spray | Biotene Dry Mouth Oral Rinse and<br>Biotene Moisturizing Mouth Spray |
| FDA Class | Unclassified | Unclassified |
| Regulation | Unclassified | Unclassified |
| Manufacturer | GuruNanda, LLC | GSK Consumer Healthcare |
| Product Family | Oral Rinse & Oral Spray | Oral Rinse & Oral Spray |
| Sold Sterile | No | No |
| Target Population | Unsupervised consumer use | Unsupervised consumer use |
| Anatomical Site | Mouth | Mouth |
| Method of Use | Ready to use liquid | Ready to use liquid |
| Disease State | Xerostomia | Xerostomia |
| Mode of Action | Contains ingredients that | Contains ingredients that |
| | temporarily substitute the<br>feel of natural saliva to<br>moisturize, lubricate and<br>refresh the mouth, thereby<br>diminishing dry mouth<br>discomfort | temporarily substitute the feel of<br>natural saliva to moisturize,<br>lubricate and refresh the mouth,<br>thereby diminishing dry mouth<br>discomfort |
| Intended Use /<br>Indications for Use | Relieve the symptoms of dry<br>mouth: refresh, moisturize,<br>clean, soothe oral irritation,<br>and lubricate oral dryness | Relieve the symptoms of dry<br>mouth: refresh, moisturize, clean,<br>soothe oral irritation, and lubricate<br>oral dryness |
| Labeling /<br>Instructions for Use | Consumer use instructions<br>on labels | Consumer use instructions on<br>labels |
| Applications Per Day | As needed | As needed |
| Appearance | Clear, water-thin liquid | Clear, water-thin liquid |
| Color | Colorless | Colorless |
| Odor | Characteristic (Mint) | Characteristic (Mint) |
| Biocompatibility | Cytotoxicity, sensitization,<br>irritation tested and passed<br>in conformity with ISO<br>10993-5, ISO 10993-10,<br>10993-23 | Cytotoxicity, sensitization,<br>irritation tested and passed in<br>conformity with ISO 10993-5, ISO<br>10993-10, 10993-23 |
| Shelf-Life | 2 years | 3 years |
| Flavor | Mint Flavor | Mint Flavor |
| Description | The GuruNanda Dry Mouth<br>Oral Rinse, GuruNanda Dry<br>Mouth Oral Spray, are<br>specifically formulated as an<br>artificial saliva substitute<br>with water, moisturizers,<br>humectants, sweeteners,<br>and flavors that collectively<br>have lubricating, | Biotene Dry Mouth products are<br>formulated as an artificial saliva<br>substitute with water,<br>moisturizers, humectants,<br>sweeteners, and flavors that<br>collectively have lubricating,<br>moisturizing, soothing, and<br>refreshing properties to help |
| | moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth (xerostomia) | relieve and manage the symptoms of dry mouth (xerostomia) |

### Comparison of GuruNanda Dry Mouth Products with Biotene (K123731) Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are stacked on top of each other in a brown, sans-serif font. There is a swoosh-like line above the word "Nanda". The "R" symbol is in the bottom right corner of the logo.

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Image /page/7/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are stacked on top of each other in a brown, cursive font. There is a curved line above the word "Nanda" and below the word "Guru". The "R" symbol is in the bottom right corner of the logo.

### 6645 Caballero Blvo. Buena Park, CA 90620 | [phone] Office | www.GuruNanda.com

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Image /page/8/Picture/0 description: The image shows the logo for Guru Nanda. The words "Guru Nanda" are written in a brown, sans-serif font. There is a curved line above the word "Nanda". The logo is simple and clean, and it is likely used to represent a company or brand.

Caballero Blvd. Buena Park, CA 90620 | [phone] Office | www.GuruNanda.com

# Discussion of differences:

As shown in the side-by-side comparison of the GuruNanda Dry Mouth Oral Rinse and Oral Spray and the predicate device, Biotene Dry Mouth products (K123731), the artificial saliva products are virtually identical in formulation. The variations in the formula / composition do not affect the function, indications or equivalency of the proposed products, they are primarily related to ingredients used as preservatives.

In summary, these differences in formulation to the predicate devices do not alter the function, indications, or substantial equivalency of the products. Additionally, the variations in the formula / composition 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.

Based on the side-by-side comparison table above, it is apparent that GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray are not different in intended use and share the same fundamental technological characteristics. The minor design differences in the chemical compositions between the products and the product offerings (oral rinse, spray) does not raise different questions of safety and effectiveness than the predicate device. Based on the data presented, GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are artificial saliva that are substantially equivalent to Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray.

### Conclusion:

Based upon the similarity of the intended use and fundamental technology, together with the evaluation of physical and chemical characteristics, the GuruNanda Dry Mouth Oral Rinse and GuruNanda Oral Spray are substantially equivalent to Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray(K123731) in intended use, design, materials, chemical composition, and performance.