Young Silver Fluoride Hypersensitivity Varnish is indicated for the treatment of dental hypersensitivity in adults. It is intended for professional use only.

Device Description

Young Silver Fluoride Hypersensitivity Varnish is a formulation of silver, sodium fluoride, chitosan, acetic acid, and purified water intended for the treatment of dental hypersensitivity in adults. It is intended for professional use only.

Like other 510(k) cleared dental hypersensitivity varnishes including the predicate device, the proposed device works by physically occluding dentinal tubules through its silver and fluoride components. It contains small silver particles to facilitate their entry into the dentinal tubules, as well as chitosan and acetic acid to evenly disperse the solution. The product is supplied in a 10mL bottle with a dropper dispensing tip.

One to two drops of the varnish can treat up to 8 sites. If needed, a second application of the varnish may be administered after 1 week.

AI/ML Overview

The provided text describes a 510(k) submission for a dental varnish. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study with acceptance criteria often associated with AI/software medical devices. Therefore, the information needed to answer the questions about acceptance criteria for AI/software device performance is not present in this document.

The document discusses performance testing in a general product development sense (e.g., bench testing, biocompatibility, shelf life) to show the new device performs "as well or better than" the predicate, but these are not the quantitative acceptance criteria for AI model performance (e.g., sensitivity, specificity, AUC) that the prompt is looking for.

Specifically, there is no mention of:

Acceptance criteria table for AI performance: The document does not define specific metrics (e.g., sensitivity, specificity, accuracy) for an AI model.
Study proving device meets acceptance criteria: There is no clinical study described that evaluates an AI model's performance on a test set. The "study" mentioned refers to bench testing (dentinal occlusion, ion release) and biocompatibility for a physical dental varnish.
Sample size for a test set or data provenance: No test set of patient data for AI model evaluation is discussed.
Number of experts or qualifications for ground truth: No expert review for labeling images/data for AI training or testing is mentioned.
Adjudication method for a test set: Not applicable as there's no AI test set.
MRMC comparative effectiveness study: No study involving human readers with and without AI assistance is described.
Standalone (algorithm only) performance: Not applicable as it's not an AI algorithm.
Type of ground truth used: For a physical dental varnish, ground truth would relate to its physical and chemical properties, not diagnostic outcomes based on expert consensus or pathology data for an AI.
Sample size for training set, or how its ground truth was established: Not applicable as there's no AI training set.

In conclusion, the provided document does not contain the information requested because it pertains to a chemical dental product (varnish) and its 510(k) clearance based on substantial equivalence, not an AI/software medical device.

Summary

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February 28, 2005

Young Dental Manufacturing Co. 1, LLC Brian Prange Director, Product Development 13705 Shoreline Ct. East Earth City, Missouri 63045

Re: K241041

Trade/Device Name: Silver Fluoride Hypersensitivity Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: PHR Dated: January 27, 2025 Received: January 27, 2025

Dear Brian Prange:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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. ADJODHA -S

Michael E. Adjodha, MChE, RAC, 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

Submission Number (if known)

K241041

Device Name

Silver Fluoride Hypersensitivity Varnish

Indications for Use (Describe)

Young Silver Fluoride Hypersensitivity Varnish is indicated for the treatment of dental hypersensitivity in adults.

It is intended for professional use only.

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

K241041

Premarket Notification (510(k)) Number
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Submitter's Name	Young Dental Manufacturing Co. 1, LLC13705 Shoreline Ct. EastEarth City, MO 63045Telephone: (314) 344-0010
Contact Person	Brian PrangeDirector of Product DevelopmentYoung Dental Manufacturing Co. 1, LLC13705 Shoreline Ct. EastEarth City, MO 63045
Establishment Registration Number	1941138
Date Prepared	February 28, 2025
Device Trade Name	Young Silver Fluoride HypersensitivityVarnish
Device Common Name	Cavity Varnish
Classification Name	Cavity Varnish
Product Code	PHR
Device Classification	Class II
Panel	Dental
Regulatory Classification	21 CFR 872.3260
Type of 510(k) Submission	Traditional
Legally Marketed Predicate Device	Elevate Advantage Arrest (K102973)

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Description

One to two drops of the varnish can treat up to 8 sites. If needed, a second application of the varnish may be administered after 1 week.

Indications for Use

Young Silver Fluoride Hypersensitivity Varnish is indicated for the treatment of dental hypersensitivity in adults. It is intended for professional use only.

Predicate Device

Young Silver Fluoride Hypersensitivity Varnish is substantially equivalent to the Elevate Advantage Arrest Hypersensitivity Varnish cleared under K102973. Both devices are intended for the treatment of dental hypersensitivity in adults. Both the subject and predicate devices also have similar technological characteristics. In particular, both devices contain silver and fluoride to physically occlude dentinal tubules in the treatment of dental hypersensitivity.

Please refer to the Substantial Equivalence Summary Comparison Table below for a summary of the similarities and differences between the subject and predicate devices.

Description of Operation/Use

After cleaning the tooth/teeth to be treated and adjacent teeth with a non-fluoride prophylaxis paste and prophy cup, the condition of the teeth should be assessed. Only teeth with normal pulp status should be treated. The affected area of the tooth is isolated with cotton rolls and gingival tissue of the affected tooth is protected with petroleum jelly or similar. Alternatively, a rubber dam or saliva evacuator can be used to isolate the area.

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One to two drops of solution (i.e., the subject device) can treat up to 8 sites per patient. The solution is dispensed from the device bottle's dropper tip into a disposable dappen dish. Ensuring that the affected tooth surface is dry, a small brush applicator is used to carefully transfer the solution directly to the affected tooth surface, which is allowed to air dry.

All protective/isolation materials used in the mouth are removed and the dappen dish and applicators are discarded in accordance with local regulations. If needed, a second application may be administered after 1 week.

Young Silver Fluoride Hypersensitivity Varnish is a prescription device intended for professional use only.

Technological Characteristics Summary

Young Silver Fluoride Hypersensitivity Varnish is substantially equivalent to Elevate Advantage Arrest (K102973) with respect to intended use, principle of operation/use, technological characteristics, and performance.

Both devices are cavity varnishes with the same intended use and the same key functional ingredients (silver and fluoride) that physically occlude dentinal tubules in the treatment of hypersensitivity. While the diamine (ammonia component) in the predicate device is used to allow the silver and fluoride to be in an evenly dispersed solution, the subject device uses acetic acid and chitosan to evenly disperse the solution. The subject device includes small silver particles to facilitate their entry into the dentinal tubules. These differences do not affect the overall means by which the silver and fluoride in the subject and predicate devices are used to occlude dentinal tubules in the treatment of dental hypersensitivity and do not raise new questions of safety or effectiveness.

Characteristic	Young SilverFluorideHypersensitivityVarnish(Subject Device)	Elevate AdvantageArrest (K102973)	Comparison
Classification Name	Cavity Varnish	Cavity Varnish	Identical
CFR Citation	21 CFR 872.3260	21 CFR 872.3260	Identical
Classification Panel	Dental	Dental	Identical
Classification	Class II	Class II	Identical
Product Code	PHR	PHR	Identical
Characteristic	Young SilverFluorideHypersensitivityVarnish(Subject Device)	Elevate AdvantageArrest (K102973)	Comparison
Product CodeDescription	Diamine SilverFluoride DentalHypersensitivityVarnish	Diamine SilverFluoride DentalHypersensitivityVarnish	Although the proposedproduct does notinclude diamine silver,the diamine (ammoniacomponent) in thepredicate device isused to allow thesilver and fluoride tobe in an evenlydispersed solution,while the proposeddevice uses acetic acidand chitosan to evenlydisperse the solution.Both devices containsilver and fluoride tophysically occlude thedentinal tubules in thetreatment of dentalhypersensitivity,therefore thesedifferences do notraise differentquestions of safety oreffectiveness.Performance testingdemonstrates thesubject deviceoccludes dentinaltubules and releasessilver and fluorideions comparably to thepredicate device.
Active Ingredients	0.20% silver3.00% sodium fluoride	38% silver diaminefluoride	Both formulationscontain silver and
Characteristic	Young SilverFluorideHypersensitivityVarnish(Subject Device)	Elevate AdvantageArrest (K102973)	Comparison
Device Description	Varnish containingsilver and fluorideapplied directly toaffected tooth or teethin the treatment ofdentalhypersensitivity.	Varnish containingsilver and fluorideapplied directly toaffected tooth or teethin the treatment ofdentalhypersensitivity.	fluoride to achieve theintended effect ofoccluding dentinaltubules in thetreatment ofhypersensitivity. Thesubject productincludes silver andfluoride, but not silverdiamine fluoride (i.e.,ammonia).Biocompatibilitytesting has beensuccessfullycompleted for thesubject device.Similar. Both deviceshave the sameintended use and thesame functionalingredients (silver andfluoride) to physicallyocclude dentinaltubules in thetreatment of dentalhypersensitivity. Thesubject deviceadditionally includeschitosan and aceticacid to evenly dispersethe solution and omitsthe diamine(ammonia) used in thepredicate.
Characteristic	Young SilverFluorideHypersensitivityVarnish(Subject Device)	Elevate AdvantageArrest (K102973)	Comparison
Intended Use/Indications for Use	Treatment of dentalhypersensitivity inadults	Treatment of dentalhypersensitivity inadults	Identical
TechnologicalCharacteristics	Composition:Colloidal silverand silver cationmixture Sodium fluoride Chitosan Acetic acid Purified water	Composition:38% silverdiamine fluoride Note: beyond thepublic disclosure of38% silver diaminefluoride, the exactformulation of ElevateAdvantage Arrest isproprietary. Indentistry practice,silver diamine fluorideis commonly preparedby mixing powderedsilver fluoride into anammonia/watermixture as follows:25% silver8% ammonia	Similar. Both devicescontain silver andfluoride to occludedentinal tubules in thetreatment of dentalhypersensitivity. Theproposed devicecontains small silverparticles to facilitatetheir entry into thedentinal tubules aswell as chitosan andacetic acid to evenlydisperse the solution.These differences donot affect the overallmeans by which thedentinal tubules areoccluded in thetreatment of
Characteristic	Young SilverFluorideHypersensitivityVarnish(Subject Device)	Elevate AdvantageArrest (K102973)	Comparison
		5% fluoride62% water	hypersensitivity nor dothey raise newquestions of safety andeffectiveness.Performance testingdemonstrates thesubject deviceoccludes dentinaltubules and releasessilver and fluorideions comparably to thepredicate device.
pH	Acid	Strong Base	While the proposedproduct has an acid pHand the predicate is astrong base(ammonia), thesedifferences do notaffect safety oreffectiveness. Theammonia in thepredicate device isused to allow thesilver and fluoride tobe in an evenlydispersed solution,while the proposeddevice uses acetic acidand chitosan to evenlydisperse the solution.In addition, the subjectdevice is used no morefrequently, andpotentially lessfrequently than the
Characteristic	Young SilverFluorideHypersensitivityVarnish(Subject Device)	Elevate AdvantageArrest (K102973)	Comparison
Mechanism of Action	Like other dentalhypersensitivitydevices, theformulation works byphysically occludingdentinal tubules. Likeother silver fluorideformulations clearedunder the 510(k)process, treatment ofdental hypersensitivityis achieved by thesilver and fluoridecomponents of theformulation, whichphysically plug orclose exposed dentinaltubules.	Like other dentalhypersensitivitydevices, theformulation works byphysically occludingdentinal tubules. Likeother silver fluorideformulations clearedunder the 510(k)process, treatment ofdental hypersensitivityis achieved by thesilver and fluoridecomponents of theformulation, whichphysically plug orclose exposed dentinaltubules.	predicate device, sincethe subject andpredicate devices mayboth be applied onceor twice, while thepredicate device mayadditionally be applieda third time.Similar – both devicesinclude silver andfluoride and treatdental hypersensitivityby physicallyoccluding dentinaltubules. Performancetesting demonstratesthe subject deviceoccludes dentinaltubules and releasessilver and fluorideions comparably to thepredicate device.
Number of ApplicationSteps	1-step	1-step	Same
Method of Application	One drop treats up to 8sites	One drop treats 5 sites	Similar
Number ofApplications	Up to two	Up to three	Similar. Subjectdevice has lowermaximum frequencyof use

Substantial Equivalence Summary Comparison Table

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Performance Testing

As described below, comprehensive bench and biocompatibility was submitted to confirm product conformance with device requirements and substantially equivalent performance as the predicate device. Performance data demonstrated dentinal occlusion and silver and fluoride ion release were comparable to the predicate device. Additional testing included transportation, stability/shelf life, device lifetime testing, and simulated use and functional testing. The key studies summarized below demonstrate that the device is as safe, as effective, and performs as well or better than the legally marketed predicate device.

In addition, predicate device characterization testing was also performed.

Biocompatibility Testing

Biocompatibility testing was conducted in accordance with ISO 10993. Testing included cytotoxicity, sensitization, irritation, oral toxicity, and genotoxicity. Other endpoints evaluated in the Biological Evaluation Report included subacute/subchronic toxicity and implantation.

Key Bench Testing

Dentinal Occlusion Testing: Dentinal occlusion testing was conducted to compare the subject and predicate devices with respect to their ability to occlude human dentine tubules. A scanning electron microscope (SEM) was used to capture images of the dentine samples and trained assessors graded the occlusion achieved by the test varnishes on a 5-point occlusion scale ranging from 1 (occluded) to 5 (unoccluded). SEM images of the dentine tubules of each sample were captured at 3000X magnification. One representative SEM image of the dentine tubules of each sample was additionally captured at 500X magnification. The study demonstrated that the subject device performed as well or better than the predicate device in occluding dentinal tubules.

Ion Release Testing: The subject and predicate devices were evaluated and compared with respect to the release of free fluoride and silver ions into deionized water solutions for 7 days. Both the subject and predicate devices were effective at releasing free fluoride ions and free silver ions once they were inserted into deionized water. Both devices had similar release profiles, with the majority of fluoride and silver ions released within the first 15 minutes. The percentages of silver released over 7 days was comparable between the subject and predicate devices.

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Hydraulic Conductance Testing: The study used human dentine samples as the test substrate to evaluate the ability of a single application of four varnish treatments versus a negative control to occlude dentine tubules when assessed via hydraulic conductance. A worst-case formulation of the subject device with 2.72% sodium fluoride (vs. 3% in the final formulation) was compared against the predicate device (Elevate Advantage Arrest), Riva Star (K172047), Colgate PreviDent Varnish, and deionized water as a control. The mean percentage reduction in microfluidic flow was highest for Elevate Advantage Arrest, followed by Young formulation. The Young Varnish performed significantly better than the PreviDent Varnish and deionized water control. The Young Varnish also had a much larger reduction in flow than the Riva Star varnish, though the difference was not statistically significant.

Device Lifetime Testing: This study confirmed a variety of device attributes in a simulated device lifetime evaluation where the samples were subjected to approximately three times the exposure to air and sunlight as expected during normal use. The study demonstrated that the device and packaging configuration can withstand a typical device lifetime without experiencing any significant damage or product degradation.

Transportation Testing: Packaged product was exposed to hot, cold and ambient conditions and subjected to simulated shipping conditions according to ASTM D4169 Schedule 13 guidelines. Shipper boxes, unit boxes and product bottles were visually assessed for damage, legibility of labeling, evidence of leaking, and other attributes. All testing was successfully completed, demonstrating that the packaging configuration can withstand a distribution evaluation.

Shelf Life Testing

Accelerated and real-time stability studies of the subject device were conducted to support the proposed shelf life. The products were packaged in the intended packaging (including bottle with dispensing tip and cap) and subjected to accelerated conditions and evaluated at relevant time points. Product was evaluated for a range of functional and specification attributes after both accelerated and real-time conditions. All measures passed all tests for all test conditions to support the labeled shelf life.

Conclusions

The bench, biocompatibility and stability/shelf life studies demonstrated the subject device is (1) biocompatible; (2) maintains device and package integrity over the labeled shelf and usage life; and (3) has substantially equivalent performance to the predicate device with respect to dentinal tubule occlusion and silver and fluoride ion release. These results demonstrate that Young Silver

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Fluoride Hypersensitivity Varnish is as safe, as effective, and performs as well or better than the legally marketed predicate device.

Summary

In summary, Young Silver Fluoride Hypersensitivity Varnish is substantially equivalent to the predicate Elevate Advantage Arrest varnish with respect to intended use, technological characteristics and performance. The biocompatibility and bench studies concluded that the device is as safe, as effective, and performs as well or better than the legally marketed predicate device.

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.