(353 days)
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.
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.
The provided text describes the acceptance criteria and performance data for the Dentilube dry mouth spray (K202689). The study is a non-clinical performance test to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study with human readers or a standalone algorithm performance study.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by demonstrating "similarity" or "sameness" to the predicate device, BioXtra® Moisturizing Gel (K072306), across various attributes and physical properties. The performance is reported against these comparative attributes.
| Attribute / Acceptance Criteria (Similarity to Predicate) | Reported Device Performance (Dentilube dry mouth spray) |
|---|---|
| Product | Dentilube dry mouth spray |
| Manufacturer | Oxy2plus, LLC |
| 510(K) # | K202689 |
| Product Code | LFD (Same as predicate) |
| Regulation | Pre-Amendment (Same as predicate) |
| Class | Unclassified (Same as predicate) |
| Review Panel | Dental (Same as predicate) |
| Indications for Use | Symptomatic relief from effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors, and other oral symptoms associated with dry mouth. (Same as predicate) |
| Mode of Action | Moisturizing and lubricating oral dryness (Same as predicate) |
| Dosage Form | Oral spray (Same as predicate) |
| Type of Product | Liquid solution (Same as predicate) |
| Area of Use | Oral cavity (Same as predicate) |
| Presentation Rx/OTC | Non-sterile OTC. (Predicate is Non-sterile Rx/OTC; subject device is OTC only) |
| Disease State | Xerostomia (Same as predicate) |
| Method of Use | Ready to use gel spray (Same as predicate) |
| Application per Day | As needed (Same as predicate) |
| Solvent | Purified water (Same as predicate) |
| Buffers | Dipotassium hydrogen phosphate, Potassium dihydrogen phosphate. (Similar to predicate's Potassium phosphate, dibasic & Sodium Chloride; both are GRAS and provide similar pH) |
| Humectants/Thickeners | Sodium carboxymethyl-cellulose. (Similar to predicate's Hydroxyethyl cellulose, Polyacrylic acid, Sodium polyacrylate, Hydrogenated starch hydrolysates (HSH); both are GRAS and provide similar viscosity/moisture-retaining quality) |
| Preservatives | Methyl P-hydroxybenzoate (Methylparaben). (Similar to predicate's Sodium methylparaben, Sodium propylparaben, Sodium benzoate, Potassium sorbate, Citric acid monohydrate, Lactoperoxidase; both are GRAS and used for maintaining/extending shelf life) |
| Colorant | FD&C Red 40 Dye (2%) (Predicate has None; colorant does not affect use) |
| Sweeteners | Sorbitol. (Similar to predicate's Sorbitol, Xylitol, Sodium Saccharin; both use sorbitol to balance solution and provide denser solution) |
| Electrolytes | Calcium chloride anhydrous, Magnesium Chloride anhydrous, Potassium Chloride, Sodium fluoride. (Similar to predicate's Calcium chloride dihydrate, Magnesium chloride hexahydrate, Potassium Chloride, Sodium monofluorophosphate; both contain electrolytes similar to natural saliva) |
| Environment of Use | Home and Clinic (Same as predicate) |
| Flavors | Lemon / Mint (Predicate is Mint; not considered a significant difference affecting intended use) |
| Appearance | Clear Viscous Liquid (Same as predicate) |
| Color | Reddish Pink (Predicate is Light Straw; different color does not affect use) |
| pH | 6.35 (Predicate is 6.82; similar, both near natural saliva pH 5.3-7.8) |
| Solubility | Water Soluble (Same as predicate) |
| Viscosity @25°C [RVT Spindle #5@10rpm] | 3500 cps (3.5 Pa-s) (Predicate is 2900 cps (2.9 Pa-s); similar, greater than natural saliva viscosity 0.0078 Pa-s) |
| Specific gravity (SPG) | 1.02 (Predicate is 1.05; similar, not significantly different from saliva SPG 1.000-1.010) |
| Sterility | Non-sterile (Same as predicate) |
| Shelf Life | 2 years (Same as predicate) |
| Biocompatibility | Conforms with ISO 10993-1 (cytotoxicity, sensitization, irritation) (Same as predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a specific "test set" in the context of a clinical study with human subjects. The performance testing described is primarily non-clinical performance testing (e.g., pH, viscosity, specific gravity, shelf-life, biocompatibility). It aims to demonstrate that the physical and chemical properties of the device are substantially equivalent to the predicate device. Therefore, a sample size for a clinical test set is not applicable here.
The data provenance is not specified beyond being generated by Oxy2plus, LLC for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study involving expert assessment of images or clinical outcomes. The "ground truth" for the non-clinical tests are standard physical and chemical measurements (e.g., pH meter readings, viscometer readings).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process is described as this is a non-clinical, comparative assessment of product characteristics.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document describes a medical device (dry mouth spray), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests:
- Physical Property Measurements: The ground truth for properties like pH, viscosity, specific gravity, and solubility are the direct measurements obtained through standard laboratory instruments and methods.
- Shelf-Life/Stability: Determined by degradation studies over time.
- Biocompatibility: Determined by adherence to ISO 10993 standards (e.g., cytotoxicity assays, sensitization studies, irritation tests).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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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
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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 (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 mouthspray | BioXtra® MoisturizingGel | - |
| 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 forUse | Dentilube dry mouth sprayis indicated for thesymptomatic relief fromthe effects of chronic ortemporary xerostomia (drymouth), mouth discomfort,mouth odors and other oralsymptoms associated withdry mouth. | BioXtra® is indicatedfor the symptomaticrelief from the effects ofchronic or temporaryxerostomia (dry mouth),mouth discomfort,mouth odors and otheroral symptomsassociated with drymouth. | Same; both areindicated forrelief ofsymptoms ofxerostomia (drymouth). |
Characteristics of the device compared to the predicate device Substantial Equivalence Comparison Chart
| Conditions of Use | Mode ofAction | Moisturizing andlubricating oral dryness | Moisturizing andlubricating oral dryness | Same | |||
|---|---|---|---|---|---|---|---|
| Dosage Form | Oral spray | Oral spray | Same | Type ofProduct | Liquid solution | Liquid solution | Same |
| Area of Use | Oral cavity | Oral cavity | Same | PresentationRx/OTC | Non-sterileOTC | Non-sterileRx/OTC | sameThe subjectdevice is OTConly |
| 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 |
| Applicationper Day | As needed | As needed | Same | Buffers | Dipotassium hydrogenphosphatePotassium dihydrogenphosphate | Potassium phosphate,dibasicSodium Chloride | Similar. Thesedifferentbuffering agentsare generallyrecognized assafe (GRAS) andprovide similarpH levels for theboth devices. |
| Packaging | 50 mL and 100 mL inPET bottle with sprayhead | 50 mL in PET bottlewith spray head | Same | Humectants/Thickeners | Sodium carboxymethyl-cellulose | Hydroxyethyl cellulosePolyacrylic acidSodium polyacrylateHydrogenated starchhydrolysates (HSH) | Similar. Thesedifferent thickeneragents are generallyrecognized as safe(GRAS) and providesimilar viscosity andmoisture-retainingquality for bothdevices. |
| Area of Use | Oral cavity | Oral cavity | Same | Preservatives | Methyl P-hydroxybenzoate(Methylparaben) | Sodium methylparabenSodium propylparabenSodium benzoatePotassium sorbateCitric acid monohydrateLactoperoxidase(Hydrogen-peroxideoxidoreductase) | Similar. Thesepreservative agentsare generallyrecognized as safe(GRAS) by theUSFDA and are usedfor maintaining andextending shelf life. |
| Environmentof Use | Home and Clinic | Home and Clinic | Same | Colorant | FD&C Red 40 Dye(2%) | None | Colorant is notused in thepredicate device |
| Sweeteners | Sorbitol | SorbitolXylitolSodium Saccharin | Similar. Thepredicate has moresweeteners. Bothdevices use sorbitolto balance thesolution and toprovide a densersolution. |
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| Electrolytes | Calcium chloride,anhydrousMagnesium Chloride,anhydrousPotassium ChlorideSodium fluoride | Calcium chloride,dihydrateMagnesium chloride,hexahydratePotassium ChlorideSodium monofluoro-phosphate | Similar. Both devicescontain electrolytessimilar to thosefound in naturalsaliva. |
|---|---|---|---|
| -------------- | ------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- |
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 colordoes not affectuse |
| pH | 6.35 | 6.82 | Similar. Bothsubject andpredicatedevices have pHvalues near thatof natural saliva(5.3 - 7.8) |
| Solubility | Water Soluble | Water Soluble | Same |
| Viscosity@25°C [RVTSpindle#5@10rpm] | 3500 cps (3.5 Pa-s) | 2900 cps (2.9 Pa-s) | Similar. Thevalues aregreater viscosityof natural saliva(0.0078 Pa-s). |
| Specific gravity(SPG) | 1.02 | 1.05 | Similar. Thevalues are notsignificantlydifferent whencompared to theSPG of thesaliva (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 ISO10993-1• cytotoxicity• sensitization• irritation | Conforms with ISO10993-1• 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.
N/A