Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on the chemical composition and physical properties of the spray, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

Yes
The device is intended to provide symptomatic relief from the effects of dry mouth and associated oral symptoms, which falls under the definition of a therapeutic effect.

Diagnostic

No

The device is indicated for symptomatic relief and mimics saliva to moisturize and refresh the mouth. It does not identify or diagnose a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "viscous pink electrolyte-containing solution" supplied in "PET bottles," indicating it is a physical product (a liquid spray) and not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the symptomatic relief of dry mouth and associated oral symptoms. This is a therapeutic or palliative use, not a diagnostic one.
Device Description: The device is a solution designed to mimic saliva and provide lubrication and moisture. It does not involve testing samples from the human body to provide information about a physiological state, disease, or condition.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, saliva, etc.) or providing diagnostic information.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Dentilube dry mouth spray is applied in vivo (inside the body) for symptomatic relief.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LFD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home and Clinic

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)

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.

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.

K072306

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

Regulation Number and Section

N/A

Summary

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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

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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)

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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

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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

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| 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.

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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.