← Product Code LFD · K202689 # Dentilube Spray (K202689) _Oxy2plus, LLC · LFD · Sep 3, 2021 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K202689 ## Device Facts - **Applicant:** Oxy2plus, LLC - **Product Code:** LFD - **Decision Date:** Sep 3, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use Dentilube dry mouth spray is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth. ## Device Story Dentilube dry mouth spray is a viscous, electrolyte-containing solution designed to mimic natural saliva. It functions as an artificial saliva substitute to moisturize and lubricate the oral cavity. The device is supplied in 50mL or 100mL PET bottles with a spray head. It is intended for use in home and clinical settings by patients suffering from xerostomia. The user applies the spray to the oral cavity as needed. By providing a lubricating and moisturizing coating, the spray relieves symptoms of dry mouth, discomfort, and odors, thereby improving patient comfort. ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10). Shelf-life/stability testing supports a 24-month expiration. No clinical trials were conducted; a 'Use Study' was mentioned but no clinical data or results were provided. ## Technological Characteristics Viscous electrolyte-containing solution; ingredients include purified water, sodium carboxymethyl-cellulose (thickener), dipotassium hydrogen phosphate/potassium dihydrogen phosphate (buffers), sorbitol (sweetener), and methylparaben (preservative). Packaged in 50mL/100mL PET bottles. Non-sterile. Biocompatibility conforms to ISO 10993 standards. pH 6.35; viscosity 3500 cps. ## Predicate Devices - BioXtra® Moisturizing Gel ([K072306](/device/K072306.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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font. September 3, 2021 Oxy2plus, LLC Chun Lin Co-Founder 4120 Rosemead Blvd Rosemead, California 91770 Re: K202689 Trade/Device Name: Dentilube Spray Regulatory Class: Unclassified Product Code: LFD Dated: June 28, 2021 Received: July 7, 2021 Dear Chun Lin: 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. Michael E. Adiodha. M.ChE. 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 510(k) Number (if known) K202689 #### Device Name Dentilube dry mouth sprav Indications for Use (Describe) Dentilube dry mouth spray is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth. 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." {3}------------------------------------------------ ### 510(K) SUMMARY (K202689) This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. #### SUBMITTER INFORMATION 1. | Name: | Oxy2plus, LLC | |------------------------|-----------------------| | Address: | 4120 Rosemead | | | Blvd Rosemead, | | | CA 91770 | | Contact person: | Chun Nan Lin, DDS, MS | | Telephone: | 626-286-7800 | | FAX: | 626-286-7600 | | Email: | oxy2plus@outlook.com | | Date Summary Prepared: | June 26, 2021 | ### 2. DEVICE NAME | Device Name: | Dentilube dry mouth spray | |----------------------------|-----------------------------------| | Trade or Proprietary Name: | Dentilube dry mouth spray | | Common or Usual Name: | Saliva, Artificial Classification | | Name: | Saliva, Artificial | | Product Code: | LFD | | Classification: | Unclassified | | Panel: | Dental | ## 3. IDENTIFICATION OF EQUIVALENCE (Predicate Device): BIO-X HEALTHCARE S.A. BioXtra® Moisturizing Gel (K072306) ## 4. DEVICE DESCRIPTION Dentilube dry mouth spray is a viscous pink electrolyte-containing solution that is designed to mimic the compositions and actions of saliva to moisturize, and refresh the mouth. It provides a lubricating and moisturizing coating inside the mouth, thereby relieving symptoms of dry mouth. The product is supplied in 50mL or 100 mL PET bottles. ## 5. STATEMENT OF INTENDED USE {4}------------------------------------------------ Dentilube dry mouth spray is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth. # 6. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS | Attributes | Subject Device | Predicate Device | Comparison | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Product | Dentilube dry mouth
spray | BioXtra® Moisturizing
Gel | - | | Manufacturer | Oxy2plus, LLC | Bio-X Healthcare S.A. | - | | 510(K) # | K202689 | K072306 | - | | Product Code | LFD | LFD | Same | | Regulation | Pre-Amendment | Pre-Amendment | Same | | Class | Unclassified | Unclassified | Same | | Review Panel | Dental | Dental | Same | | Indications for
Use | Dentilube dry mouth spray
is indicated for the
symptomatic relief from
the effects of chronic or
temporary xerostomia (dry
mouth), mouth discomfort,
mouth odors and other oral
symptoms associated with
dry mouth. | BioXtra® is indicated
for the symptomatic
relief from the effects of
chronic or temporary
xerostomia (dry mouth),
mouth discomfort,
mouth odors and other
oral symptoms
associated with dry
mouth. | Same; both are
indicated for
relief of
symptoms of
xerostomia (dry
mouth). | Characteristics of the device compared to the predicate device Substantial Equivalence Comparison Chart | Conditions of Use | | | | Mode of
Action | Moisturizing and
lubricating oral dryness | Moisturizing and
lubricating oral dryness | Same | |------------------------|------------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dosage Form | Oral spray | Oral spray | Same | Type of
Product | Liquid solution | Liquid solution | Same | | Area of Use | Oral cavity | Oral cavity | Same | Presentation
Rx/OTC | Non-sterile
OTC | Non-sterile
Rx/OTC | same
The subject
device is OTC
only | | Disease State | Xerostomia | Xerostomia | Same | Composition | | | | | Method of Use | Ready to use gel spray | Ready to use gel spray | Same | Solvent | Purified water | Purified water | same | | Application
per Day | As needed | As needed | Same | Buffers | Dipotassium hydrogen
phosphate
Potassium dihydrogen
phosphate | Potassium phosphate,
dibasic
Sodium Chloride | Similar. These
different
buffering agents
are generally
recognized as
safe (GRAS) and
provide similar
pH levels for the
both devices. | | Packaging | 50 mL and 100 mL in
PET bottle with spray
head | 50 mL in PET bottle
with spray head | Same | Humectants/
Thickeners | Sodium carboxymethyl-
cellulose | Hydroxyethyl cellulose
Polyacrylic acid
Sodium polyacrylate
Hydrogenated starch
hydrolysates (HSH) | Similar. These
different thickener
agents are generally
recognized as safe
(GRAS) and provide
similar viscosity and
moisture-retaining
quality for both
devices. | | Area of Use | Oral cavity | Oral cavity | Same | Preservatives | Methyl P-
hydroxybenzoate
(Methylparaben) | Sodium methylparaben
Sodium propylparaben
Sodium benzoate
Potassium sorbate
Citric acid monohydrate
Lactoperoxidase
(Hydrogen-peroxide
oxidoreductase) | Similar. These
preservative agents
are generally
recognized as safe
(GRAS) by the
USFDA and are used
for maintaining and
extending shelf life. | | Environment
of Use | Home and Clinic | Home and Clinic | Same | Colorant | FD&C Red 40 Dye
(2%) | None | Colorant is not
used in the
predicate device | | Sweeteners | Sorbitol | Sorbitol
Xylitol
Sodium Saccharin | Similar. The
predicate has more
sweeteners. Both
devices use sorbitol
to balance the
solution and to
provide a denser
solution. | | | | | {5}------------------------------------------------ {6}------------------------------------------------ | Electrolytes | Calcium chloride,
anhydrous
Magnesium Chloride,
anhydrous
Potassium Chloride
Sodium fluoride | Calcium chloride,
dihydrate
Magnesium chloride,
hexahydrate
Potassium Chloride
Sodium monofluoro-
phosphate | Similar. Both devices
contain electrolytes
similar to those
found in natural
saliva. | |--------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| |--------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| The subject device, Dentilube dry mouth spray, and the predicate device have the same indications and method of use. They also share many conditions of use. Further, both employ the same fundamental scientific technology (a formulation of water, humectants or moisturizers, thickening/binding agents, buffering agents, sweeteners, flavor, surfactants and preservatives). | Physical Properties (Non-Clinical Performance) | | | | |-------------------------------------------------|----------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------| | Flavors | Lemon / Mint | Mint | | | Appearance | Clear Viscous Liquid | Clear Viscous Liquid | Same | | Color | Reddish Pink | Light Straw | Different color
does not affect
use | | pH | 6.35 | 6.82 | Similar. Both
subject and
predicate
devices have pH
values near that
of natural saliva
(5.3 - 7.8) | | Solubility | Water Soluble | Water Soluble | Same | | Viscosity
@25°C [RVT
Spindle
#5@10rpm] | 3500 cps (3.5 Pa-s) | 2900 cps (2.9 Pa-s) | Similar. The
values are
greater viscosity
of natural saliva
(0.0078 Pa-s). | | Specific gravity
(SPG) | 1.02 | 1.05 | Similar. The
values are not
significantly
different when
compared to the
SPG of the
saliva (1.000-
1.010). | #### SUMMARY OF NON-CLINICAL PERFORMANCE TESTING 7. {7}------------------------------------------------ | Sterility | Non-sterile | Non-sterile | Same | |------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------| | Shelf Life | 2 years | 2 years | Same | | Biocompatibility | Conforms with ISO
10993-1
• cytotoxicity
• sensitization
• irritation | Conforms with ISO
10993-1
• cytotoxicity
• sensitization
• irritation | Same | Dentilube dry mouth spray has been tested for shelf-life/stability, which provides for a 24-month shelf life, same as the primary predicate device. Biocompatibility assessments has been done in accordance with ISO 10993 for cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10) and has been shown to be safe for the intended use. No other clinical tests were performed other than a Use Study for this submission. #### DISCUSSION AND CONCLUSION 8. Based on the comparison of intended use and technical characteristics, as well as non-clinical performance testing, we conclude that Dentilube dry mouth spray is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K202689](https://fda.innolitics.com/device/K202689) **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