V-varnish Premium

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K160377 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {3}------------------------------------------------ ## 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ | 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 DENTAL<br>PRODUCTS CO. | - | | 510(k) Number | | | K160377 | K062683 | - | | Intended user | | | Dental professional | Dental professional | Same | | Similarity | Description | | V-varnish™ Premium is cavity<br>varnish containing 5% sodium<br>fluoride(F ion: 22,600ppm). It<br>is applied to teeth for the<br>purpose of treatment dentinal<br>hypersensitivity. V-varnish™<br>Premium consists of rosin<br>which adheres to the surface<br>of the teeth, seals exposed<br>dentin tubules. V-varnish™<br>Premium has four flavors such<br>as bubblegum, strawberry,<br>melon and mint and two<br>colors(clear and white). It is | Enamel Pro Varnish is a 5%<br>sodium fluoride varnish<br>which has a strong<br>desensitizing action when<br>applied to enamel and<br>dentin surfaces. Enamel<br>Pro Varnish may be used<br>on moist teeth and leaves<br>a film of varnish which<br>sets in the mouth to allow<br>for visual control and<br>verification of application. | Description of<br>subject device<br>and predicate<br>device is very<br>similar;<br>containing 5%<br>sodium fluoride,<br>purpose of use,<br>fundamental<br>technology etc.<br>Subject device<br>includes more<br>information<br>about flavor, | | | | | packed in single dose package<br>allows easy mixing and<br>application. | | color and<br>packaging. | | | Indication<br>for Use | | For treatment of dentinal<br>hypersensitivity secondary to<br>exposed dentin and root<br>surfaces | Enamel Pro® Varnish is a<br>fluoride containing<br>preparation for the<br>treatment of dentinal<br>hypersensitivity, and for<br>the reduction of post<br>operative sensitivity. The<br>varnish can be placed on<br>sensitive root surfaces and<br>under temporary<br>restoratives and cements<br>in order to seal exposed<br>dentinal tissue. It can be<br>used as a cavity liner. | Both devices<br>are used for<br>treatment of<br>dentinal<br>hypersensitivity.<br>But predicate<br>device is used<br>extensively<br>more subject<br>device. | | Design | | | Blister packaging<br>(Varnish + Brush) | Blister packaging<br>(Varnish + Brush) | Both devices<br>provide varnish<br>and brush in<br>plastic case. | | Similarity | Che<br>mic<br>al<br>Composition | Base<br>mate<br>rials<br>&<br>blocki<br>ng<br>denti<br>nal<br>tubul | Rosin<br>Sodium fluoride<br>Tricalcium phosphate | Rosin<br>Sodium fluoride<br>Dibasic Sodium Phosphate<br>Calcium Sulfate Dihydrate | Both devices<br>consist of rosin,<br>ethanol and<br>sodium fluoride<br>mainly. Other<br>components are<br>additives for<br>taste, flavour<br>and colour etc. | | | | e | | | | | | | Solve<br>nt | Ethanol | Ethanol | | | | | Etc. | Sweetener<br>Pigment<br>Flavor etc. | etc. | | | | | Recommend<br>ed<br>contact time | For at least 4-6 hours | For approximately 4-6 hours | Both devices<br>remain on the<br>teeth for at<br>least 4-6 hours. | | | | Physical and<br>performance properties | - Consistency : $27.14\pm0.62$ mm<br>- pH: 6.65<br>- Fluoride content:<br>$2.15\pm0.03$ %<br>- Dentinal tubule occlusion: 85% | - Consistency: $33.25\pm0.64$ mm<br>- pH: 6.69<br>- Fluoride content :<br>$1.97\pm0.05$ %<br>- Dentinal tubule<br>occlusion: 77% | According to<br>bench test<br>result, the<br>physical &<br>performance<br>properties of<br>the subjective<br>device and<br>predicate device<br>are substantial<br>equivalent. | | | Bio-<br>compatibility | | Cytotoxicity<br>Oral mucosa irritation<br>Sensitization(LLNA)<br>Genotoxicity(Ames)<br>Acute systemic toxicity | Device is biocompatible<br>when used as directed by<br>dental professionals per<br>ISO 10993-1. | Both devices<br>are<br>biocompatible | | | | Sterilization | Non-sterile | Non-sterile | Same | | | | Shelf Life | 2 years | 2 years | Same | | Difference | Flavor | | Bubblegum, Strawberry,<br>Melon,<br>Mint | VanillaMint,<br>Strawberrier'n Cream,<br>Bubblegum | Flavor is an<br>option that is<br>selected<br>according to<br>patient's taste.<br>These<br>differences do<br>not raise<br>concerns or<br>questions when<br>comparing the<br>subject device<br>to the predicate<br>device. | | | Storage<br>condition | | Do not store at elevated<br>temperature or intense light.<br>Do not use after expiry date.<br>Temperature limitation: 0-<br>30°C (32-86°F) | Keep out of direct<br>sunlight, store at room<br>temperature: 68-77°F (20-<br>25°C). Do not use after<br>expiration date. | It is a condition<br>of storage that is<br>provided from<br>manufacturer<br>for stable use<br>during shelf life.<br>These<br>differences do | | | | | | questions when<br>comparing the<br>subject device to<br>the predicate<br>device. | | | | | | | | | ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### 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. {9}------------------------------------------------ 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.