(318 days)
No
The device description and performance studies focus on the chemical and physical properties of the varnish and its ability to occlude dentinal tubules. There is no mention of AI or ML in the intended use, device description, or performance data. The testing methods described are standard bench and biocompatibility tests.
Yes
The device is indicated for the treatment of dental hypersensitivity and works by physically occluding dentinal tubules, which is a therapeutic action.
No
Explanation: The device is a varnish intended for the treatment of dental hypersensitivity by physically occluding dentinal tubules. There is no indication that it is used to diagnose a condition.
No
The device is a physical varnish formulation containing chemical components (silver, sodium fluoride, chitosan, acetic acid, purified water) intended for direct application to teeth. The description focuses on the physical and chemical properties and performance of the varnish itself, not software functionality.
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 treatment of dental hypersensitivity in adults by physically occluding dentinal tubules. This is a therapeutic action performed directly on the patient's teeth.
- Mechanism of Action: The device works by physically blocking dentinal tubules with its components. This is a physical/chemical interaction with the tooth structure, not a diagnostic test performed on a sample taken from the body.
- No mention of in vitro testing: The description and performance studies focus on the device's ability to occlude tubules, release ions, and reduce hydraulic conductance in vitro (on extracted teeth or in solution) and its biocompatibility. These are performance and safety tests, not diagnostic tests on patient samples.
- No mention of analyzing samples from the body: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not do that.
Therefore, the Young Silver Fluoride Hypersensitivity Varnish is a therapeutic dental device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
PHR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected tooth surface / dentinal tubules
Indicated Patient Age Range
adults
Intended User / Care Setting
professional use only
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
- Biocompatibility Testing: 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.
- Dentinal Occlusion Testing:
- Study type: Bench study comparing the subject and predicate devices.
- Sample size: Not specified, but involved human dentine samples.
- Key results: The study demonstrated that the subject device performed as well or better than the predicate device in occluding dentinal tubules.
- Ion Release Testing:
- Study type: Bench study evaluating and comparing the subject and predicate devices.
- Methodology: Release of free fluoride and silver ions into deionized water solutions for 7 days.
- Key results: Both devices were effective at releasing free fluoride ions and free silver ions, with similar release profiles (majority of ions released within the first 15 minutes). Percentages of silver released over 7 days were comparable.
- Hydraulic Conductance Testing:
- Study type: Bench study using human dentine samples as the test substrate.
- Methodology: Evaluated the ability of a single application of four varnish treatments (worst-case subject device formulation, predicate device (Elevate Advantage Arrest), Riva Star (K172047), Colgate PreviDent Varnish) versus a negative control (deionized water) to occlude dentine tubules when assessed via hydraulic conductance.
- Key results: 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:
- Methodology: Samples subjected to approximately three times the exposure to air and sunlight as expected during normal use.
- Key results: Demonstrated that the device and packaging configuration can withstand a typical device lifetime without experiencing any significant damage or product degradation.
- Transportation Testing:
- Methodology: Packaged product exposed to hot, cold and ambient conditions and subjected to simulated shipping conditions according to ASTM D4169 Schedule 13 guidelines. Visual assessment for damage, legibility of labeling, evidence of leaking, and other attributes.
- Key results: All testing was successfully completed, demonstrating that the packaging configuration can withstand a distribution evaluation.
- Shelf Life Testing:
- Methodology: Accelerated and real-time stability studies conducted, with products packaged in intended packaging and evaluated at relevant time points. Functional and specification attributes assessed.
- Key results: All measures passed all tests for all test conditions to support the labeled shelf life.
Key Metrics
Not Found
Predicate Device(s)
Elevate Advantage Arrest (K102973)
Reference Device(s)
Riva Star (K172047)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
3
Indications for Use
Submission Number (if known)
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)
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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510(k) Summary
K241041
| Premarket Notification (510(k)) Number | |
|---|---|
| ---------------------------------------- | -- |
| Submitter's Name | Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Ct. East
Earth City, MO 63045
Telephone: (314) 344-0010 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Prange
Director of Product Development
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Ct. East
Earth City, MO 63045 |
| Establishment Registration Number | 1941138 |
| Date Prepared | February 28, 2025 |
| Device Trade Name | Young Silver Fluoride Hypersensitivity
Varnish |
| 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
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.
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 Silver
Fluoride
Hypersensitivity
Varnish
(Subject Device) | Elevate Advantage
Arrest (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 Silver
Fluoride
Hypersensitivity
Varnish
(Subject Device) | Elevate Advantage
Arrest (K102973) | Comparison |
| Product Code
Description | Diamine Silver
Fluoride Dental
Hypersensitivity
Varnish | Diamine Silver
Fluoride Dental
Hypersensitivity
Varnish | Although the proposed
product does not
include diamine silver,
the diamine (ammonia
component) in the
predicate device is
used to allow the
silver and fluoride to
be in an evenly
dispersed solution,
while the proposed
device uses acetic acid
and chitosan to evenly
disperse the solution.
Both devices contain
silver and fluoride to
physically occlude the
dentinal tubules in the
treatment of dental
hypersensitivity,
therefore these
differences do not
raise different
questions of safety or
effectiveness.
Performance testing
demonstrates the
subject device
occludes dentinal
tubules and releases
silver and fluoride
ions comparably to the
predicate device. |
| Active Ingredients | 0.20% silver
3.00% sodium fluoride | 38% silver diamine
fluoride | Both formulations
contain silver and |
| Characteristic | Young Silver
Fluoride
Hypersensitivity
Varnish
(Subject Device) | Elevate Advantage
Arrest (K102973) | Comparison |
| Device Description | Varnish containing
silver and fluoride
applied directly to
affected tooth or teeth
in the treatment of
dental
hypersensitivity. | Varnish containing
silver and fluoride
applied directly to
affected tooth or teeth
in the treatment of
dental
hypersensitivity. | fluoride to achieve the
intended effect of
occluding dentinal
tubules in the
treatment of
hypersensitivity. The
subject product
includes silver and
fluoride, but not silver
diamine fluoride (i.e.,
ammonia).
Biocompatibility
testing has been
successfully
completed for the
subject device.
Similar. Both devices
have the same
intended use and the
same functional
ingredients (silver and
fluoride) to physically
occlude dentinal
tubules in the
treatment of dental
hypersensitivity. The
subject device
additionally includes
chitosan and acetic
acid to evenly disperse
the solution and omits
the diamine
(ammonia) used in the
predicate. |
| Characteristic | Young Silver
Fluoride
Hypersensitivity
Varnish
(Subject Device) | Elevate Advantage
Arrest (K102973) | Comparison |
| Intended Use/
Indications for Use | Treatment of dental
hypersensitivity in
adults | Treatment of dental
hypersensitivity in
adults | Identical |
| Technological
Characteristics | Composition:
Colloidal silver
and silver cation
mixture Sodium fluoride Chitosan Acetic acid Purified water | Composition:
38% silver
diamine fluoride Note: beyond the
public disclosure of
38% silver diamine
fluoride, the exact
formulation of Elevate
Advantage Arrest is
proprietary. In
dentistry practice,
silver diamine fluoride
is commonly prepared
by mixing powdered
silver fluoride into an
ammonia/water
mixture as follows:
25% silver
8% ammonia | Similar. Both devices
contain silver and
fluoride to occlude
dentinal tubules in the
treatment of dental
hypersensitivity. The
proposed device
contains small silver
particles to facilitate
their entry into the
dentinal tubules as
well as chitosan and
acetic acid to evenly
disperse the solution.
These differences do
not affect the overall
means by which the
dentinal tubules are
occluded in the
treatment of |
| Characteristic | Young Silver
Fluoride
Hypersensitivity
Varnish
(Subject Device) | Elevate Advantage
Arrest (K102973) | Comparison |
| | | 5% fluoride
62% water | hypersensitivity nor do
they raise new
questions of safety and
effectiveness.
Performance testing
demonstrates the
subject device
occludes dentinal
tubules and releases
silver and fluoride
ions comparably to the
predicate device. |
| pH | Acid | Strong Base | While the proposed
product has an acid pH
and the predicate is a
strong base
(ammonia), these
differences do not
affect safety or
effectiveness. The
ammonia in the
predicate device is
used to allow the
silver and fluoride to
be in an evenly
dispersed solution,
while the proposed
device uses acetic acid
and chitosan to evenly
disperse the solution.
In addition, the subject
device is used no more
frequently, and
potentially less
frequently than the |
| Characteristic | Young Silver
Fluoride
Hypersensitivity
Varnish
(Subject Device) | Elevate Advantage
Arrest (K102973) | Comparison |
| Mechanism of Action | Like other dental
hypersensitivity
devices, the
formulation works by
physically occluding
dentinal tubules. Like
other silver fluoride
formulations cleared
under the 510(k)
process, treatment of
dental hypersensitivity
is achieved by the
silver and fluoride
components of the
formulation, which
physically plug or
close exposed dentinal
tubules. | Like other dental
hypersensitivity
devices, the
formulation works by
physically occluding
dentinal tubules. Like
other silver fluoride
formulations cleared
under the 510(k)
process, treatment of
dental hypersensitivity
is achieved by the
silver and fluoride
components of the
formulation, which
physically plug or
close exposed dentinal
tubules. | predicate device, since
the subject and
predicate devices may
both be applied once
or twice, while the
predicate device may
additionally be applied
a third time.
Similar – both devices
include silver and
fluoride and treat
dental hypersensitivity
by physically
occluding dentinal
tubules. Performance
testing demonstrates
the subject device
occludes dentinal
tubules and releases
silver and fluoride
ions comparably to the
predicate device. |
| Number of Application
Steps | 1-step | 1-step | Same |
| Method of Application | One drop treats up to 8
sites | One drop treats 5 sites | Similar |
| Number of
Applications | Up to two | Up to three | Similar. Subject
device has lower
maximum frequency
of 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.