(117 days)
Not Found
No
The device description and intended use focus on the chemical formulation of the oral rinse and spray, with no mention of AI or ML capabilities.
Yes.
The device is intended to relieve symptoms of dry mouth such as irritation and dryness by providing lubrication and moisturizing effects, which aligns with the definition of a therapeutic device designed to alleviate medical conditions.
No
The device is intended to relieve symptoms and manage dry mouth, functioning as an artificial saliva substitute rather than diagnosing the condition.
No
The device description clearly states it is an oral rinse and spray, which are physical products (liquids) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to relieve symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness. This is a therapeutic and symptomatic relief purpose, not a diagnostic one.
- Device Description: The description highlights its function as an artificial saliva substitute with lubricating and moisturizing properties. This aligns with a treatment or management approach, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like saliva, blood, etc.) to detect a condition, measure a substance, or provide information for diagnosis.
- Predicate Device: The predicate device (Biotene Dry Mouth Oral Rinse and Spray) is also a product for managing dry mouth symptoms, not a diagnostic device.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures. This device does not fit that definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Unsupervised consumer use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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."
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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 | (866) 421-0309 Office | www.GuruNanda.com
K231205 - 510(k) Summary
510(k) Owner:
Puneet Nanda GuruNanda LLC 6645 Caballero Blvd. Buena Park, CA 90620 Telephone: 714-410-0466 E-Mail: puneet@gurunanda.com
Contact Person:
Chetan Patel GuruNanda LLC 6645 Caballero Blvd. Buena Park, CA 90620 Establishment Registration Number: 3014468707 Telephone:714-322-5024 E-Mail: chetan@gurunanda.com
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 | (866) 421-0309 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
Rinse and Oral Spray | Biotene Dry Mouth Oral Rinse and
Biotene Moisturizing Mouth
Spray (K123731) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K231205 | K123731 |
| Product Code | LFD | LFD |
| Device Common
Name | Saliva, Artificial | Saliva, Artificial |
| Device Trade Name | GuruNanda Private Label
Dry Mouth Oral Rinse and
Oral Spray | Biotene Dry Mouth Oral Rinse and
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
feel of natural saliva to
moisturize, lubricate and
refresh the mouth, thereby
diminishing dry mouth
discomfort | temporarily substitute the feel of
natural saliva to moisturize,
lubricate and refresh the mouth,
thereby diminishing dry mouth
discomfort |
| Intended Use /
Indications for Use | Relieve the symptoms of dry
mouth: refresh, moisturize,
clean, soothe oral irritation,
and lubricate oral dryness | Relieve the symptoms of dry
mouth: refresh, moisturize, clean,
soothe oral irritation, and lubricate
oral dryness |
| Labeling /
Instructions for Use | Consumer use instructions
on labels | Consumer use instructions on
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,
irritation tested and passed
in conformity with ISO
10993-5, ISO 10993-10,
10993-23 | Cytotoxicity, sensitization,
irritation tested and passed in
conformity with ISO 10993-5, ISO
10993-10, 10993-23 |
| Shelf-Life | 2 years | 3 years |
| Flavor | Mint Flavor | Mint Flavor |
| Description | The GuruNanda Dry Mouth
Oral Rinse, GuruNanda Dry
Mouth Oral Spray, are
specifically formulated as an
artificial saliva substitute
with water, moisturizers,
humectants, sweeteners,
and flavors that collectively
have lubricating, | Biotene Dry Mouth products are
formulated as an artificial saliva
substitute with water,
moisturizers, humectants,
sweeteners, and flavors that
collectively have lubricating,
moisturizing, soothing, and
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 | (866) 421-0309 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 | (866) 421-0309 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.