(296 days)
For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces
V-varnish™ Premium is cavity varnish containing 5% sodium fluoride(F ion: 22,600ppm). It is applied to teeth for the purpose of treatment dentinal hypersensitivity. V-varnish™ Premium consists of rosin which adheres to the surface of the teeth, seals exposed dentin tubules. V-varnish™ Premium has four flavors such as bubblegum, strawberry, melon and mint and two colors(clear and white). It is packed in single dose package allows easy mixing and application.
The provided document is a 510(k) summary for V-varnish™ Premium, a cavity varnish. It details a comparison study against a predicate device, Enamel Pro® Varnish (K062683). The study is for the purpose of demonstrating substantial equivalence, not conducting a comparative effectiveness study in the typical sense of human reader performance.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating that the V-varnish™ Premium's physical and performance properties are "substantially equivalent" to the predicate device, Enamel Pro® Varnish. The values for the predicate device serve as the de facto "acceptance criteria" against which the new device's performance is measured.
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (V-varnish™ Premium) |
|---|---|
| Consistency: $33.25\pm0.64$ mm | Consistency: $27.14\pm0.62$ mm |
| pH: 6.69 | pH: 6.65 |
| Fluoride content: $1.97\pm0.05$ % | Fluoride content: $2.15\pm0.03$ % |
| Dentinal tubule occlusion: 77% | Dentinal tubule occlusion: 85% |
| Biocompatible when used as directed per ISO 10993-1 | Meets ISO 10993 requirements for cytotoxicity, genotoxicity, oral mucous irritation, sensitization (LLNA), acute systemic toxicity |
| Shelf Life: 2 years | Shelf Life: 2 years |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "in vitro" tests (consistency, pH, fluoride content, dentinal tubule occlusion). It also does not specify the provenance (country of origin, retrospective/prospective) of the data for these tests. However, the tests were conducted in vitro using the devices themselves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of study does not involve expert readers establishing ground truth as it is a bench study evaluating physical and chemical properties, and biocompatibility, of a dental varnish.
4. Adjudication Method for the Test Set
Not applicable for a bench study of physical and chemical properties and biocompatibility.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) premarket notification for a medical device (cavity varnish), which relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing rather than human reader studies. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device (cavity varnish), not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the non-clinical performance tests are the measured physical and chemical properties of the devices themselves, as determined by laboratory testing. For biocompatibility, the ground truth is adherence to internationally recognized standards (ISO 10993 series).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study that requires a training set. The study involves bench testing of a physical product.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, with flowing lines connecting them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2016
Vericom Co., Ltd. Myung-Hwan Oh R&d Director 48 Toegyegongdan 1-gil, Chuncheon-si, 200-944 KR
Re: K160377
Trade/Device Name: V-varnish™ Premium Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: November 1, 2016 Received: November 4, 2016
Dear Myung-Hwan Oh:
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. 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 and Part 809) medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
V-varnish™ Premium
Indications for Use (Describe)
· For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY K160377
V-varnish™ Premium
Date:
I. SUBMITTER
Veriocm Co., Ltd. 48 Toegyegongdan 1-gil, Chuncheon-si, Gangwon-do 200-944, Korea Tel: +82-31-441-2881 Fax: +82-31-441-2883
Contact Name: Myung-Hwan Oh Email: omh@vericom.co.kr
II. DEVICE
| Name of Device: | V-varnish™ Premium |
|---|---|
| Regulation Name: | Cavity Varnish |
| Classification Name: | Cavity Varnish |
| Regulatory Class: | II |
| Product Code: | LBH |
III. PREDICATE DEVICE
K062683, Enamel Pro Varnish, PREMIER DENTAL PRODUCTS CO.
IV. DEVICE DESCRIPTION
V-varnish™ Premium is cavity varnish containing 5% sodium fluoride(F ion: 22,600ppm). It is applied to teeth for the purpose of treatment dentinal
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hypersensitivity. V-varnish™ Premium consists of rosin which adheres to the surface of the teeth, seals exposed dentin tubules. V-varnish™ Premium has four flavors such as bubblegum, strawberry, melon and mint and two colors(clear and white). It is packed in single dose package allows easy mixing and application.
V. INDICATIONS FOR USE
For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces
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| VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||||
|---|---|---|---|---|---|
| Subject Device | Predicate Device | Summary | |||
| Device Name | V-varnish™ Premium | Enamel Pro Varnish | - | ||
| Manufacturer | VERICOM CO., LTD. | PREMIER DENTALPRODUCTS CO. | - | ||
| 510(k) Number | K160377 | K062683 | - | ||
| Intended user | Dental professional | Dental professional | Same | ||
| Similarity | Description | V-varnish™ Premium is cavityvarnish containing 5% sodiumfluoride(F ion: 22,600ppm). Itis applied to teeth for thepurpose of treatment dentinalhypersensitivity. V-varnish™Premium consists of rosinwhich adheres to the surfaceof the teeth, seals exposeddentin tubules. V-varnish™Premium has four flavors suchas bubblegum, strawberry,melon and mint and twocolors(clear and white). It is | Enamel Pro Varnish is a 5%sodium fluoride varnishwhich has a strongdesensitizing action whenapplied to enamel anddentin surfaces. EnamelPro Varnish may be usedon moist teeth and leavesa film of varnish whichsets in the mouth to allowfor visual control andverification of application. | Description ofsubject deviceand predicatedevice is verysimilar;containing 5%sodium fluoride,purpose of use,fundamentaltechnology etc.Subject deviceincludes moreinformationabout flavor, | |
| packed in single dose packageallows easy mixing andapplication. | color andpackaging. | ||||
| Indicationfor Use | For treatment of dentinalhypersensitivity secondary toexposed dentin and rootsurfaces | Enamel Pro® Varnish is afluoride containingpreparation for thetreatment of dentinalhypersensitivity, and forthe reduction of postoperative sensitivity. Thevarnish can be placed onsensitive root surfaces andunder temporaryrestoratives and cementsin order to seal exposeddentinal tissue. It can beused as a cavity liner. | Both devicesare used fortreatment ofdentinalhypersensitivity.But predicatedevice is usedextensivelymore subjectdevice. | ||
| Design | Blister packaging(Varnish + Brush) | Blister packaging(Varnish + Brush) | Both devicesprovide varnishand brush inplastic case. | ||
| Similarity | ChemicalComposition | Basematerials&blockingdentinaltubul | RosinSodium fluorideTricalcium phosphate | RosinSodium fluorideDibasic Sodium PhosphateCalcium Sulfate Dihydrate | Both devicesconsist of rosin,ethanol andsodium fluoridemainly. Othercomponents areadditives fortaste, flavourand colour etc. |
| e | |||||
| Solvent | Ethanol | Ethanol | |||
| Etc. | SweetenerPigmentFlavor etc. | etc. | |||
| Recommendedcontact time | For at least 4-6 hours | For approximately 4-6 hours | Both devicesremain on theteeth for atleast 4-6 hours. | ||
| Physical andperformance properties | - Consistency : $27.14\pm0.62$ mm- pH: 6.65- Fluoride content:$2.15\pm0.03$ %- Dentinal tubule occlusion: 85% | - Consistency: $33.25\pm0.64$ mm- pH: 6.69- Fluoride content :$1.97\pm0.05$ %- Dentinal tubuleocclusion: 77% | According tobench testresult, thephysical &performanceproperties ofthe subjectivedevice andpredicate deviceare substantialequivalent. | ||
| Bio-compatibility | CytotoxicityOral mucosa irritationSensitization(LLNA)Genotoxicity(Ames)Acute systemic toxicity | Device is biocompatiblewhen used as directed bydental professionals perISO 10993-1. | Both devicesarebiocompatible | ||
| Sterilization | Non-sterile | Non-sterile | Same | ||
| Shelf Life | 2 years | 2 years | Same | ||
| Difference | Flavor | Bubblegum, Strawberry,Melon,Mint | VanillaMint,Strawberrier'n Cream,Bubblegum | Flavor is anoption that isselectedaccording topatient's taste.Thesedifferences donot raiseconcerns orquestions whencomparing thesubject deviceto the predicatedevice. | |
| Storagecondition | Do not store at elevatedtemperature or intense light.Do not use after expiry date.Temperature limitation: 0-30°C (32-86°F) | Keep out of directsunlight, store at roomtemperature: 68-77°F (20-25°C). Do not use afterexpiration date. | It is a conditionof storage that isprovided frommanufacturerfor stable useduring shelf life.Thesedifferences do | ||
| questions whencomparing thesubject device tothe predicatedevice. | |||||
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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VII. NON-CLINICAL PERFORMANCE TESTING
In vitro testing was conducted with V-varnish™ Premium and the predicate device, Enamel Pro® Varnish. Properties evaluated include consistency, pH, fluoride content and dentinal tubule occlusion.
Stability testing was conducted by evaluating the physical properties of the device to confirm a shelf life at room temperature of 24 months.
The biocompatibility evaluation for the V-varnish™ Premium was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The tests carried out for the devices and standards applied for each test are:
- · Cytotoxicity(MTT), ISO 10993-5[2009]
- · Genotoxicity, ISO 10993-3[2003]
- . Oral mucous Irritation, ISO 10993-10[2010]
- . Sensitization(LLNA), ISO 10993-10[2010]
- . Acute systemic toxicity, ISO 10993-11[2006]
V-varnish™ Premium is considered to be in contact with dentin, enamel and oral mucosa for duration of less than 24 hours, while being the external communicating device.
VIII. SUBSTANTIAL EQUIVALENCE DISCUSSION
The subject device is similar to indication for use, design, recommended contact time, chemical composition, physical & performance properties and etc. Also, the physical and performance properties of subjective device are not significant different between the subject device and the predicate device.
The subject device is composed of tricalcium phosphate while predicate device is composed of dibasic sodium phosphate and calcium sulfate dihydrate. All of these raw materials cause blockage of dentinal tubule to achieve the intended function of device. Also tricalcium phosphate of subject device is actually a resultant chemical compound from raw materials of predicate device; dibasic sodium phosphate and calcium sulfate dihydrate in oral condition.
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Both subject device and predicate device produced with same amount of sodium fluoride contents.
The flavor and storage condition are different between subject device and predicate device which do not raise question or concerns.
IX. CONCLUSIONS
Based on a comparison of technology and Indications for use, together with in vitro performance testing, the subject device of V-varnish™ Premium is substantially equivalent to the predicate of Enamel Pro Varnish.
§ 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.