Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and 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 letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Nanova Biomaterials Inc Andrew Ritts Director of Quality System Regulation and Regulatory Affairs 3806 Mojave Ct Columbia, Missouri 65202 January 16, 2018 Re: K172977 Trade/Device Name: Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: December 19, 2017 Received: December 19, 2017 Dear Andrew Ritts: 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); medical device 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); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely, Mary S. Runner -5 forTina 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) K172977 #### Device Name Nanova 2 Step Etch and Rinse Dental Adhesive Indications for Use (Describe) Nanova 2 Step Etch and Rinse Dental Adhesive is indicated for use in: - · All direct restorations - All indirect restorations - · Intra-oral repairs - · Desensitizing/sealing of tooth structure - Priming of enamel for orthodontic use | 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 | Submitted By: | | |---------------------------------|-----------------------------| | Nanova Biomaterials, Inc. | | | 3806 Mojave Ct | | | Columbia, MO 65202 | | | USA | | | 573-875-6682 | | | Contact Person: Andrew Ritts | Phone: (573) 875-6682 | | Secondary Contact: Liang Chen | Phone: (573) 875-6682 | | Establishment Registration No.: | 3011430871 | | Date Prepared: | December 19, 2017 | | Device Trade Name: | Nanova™ 2 Step Etch and R | | | Adhesive | | Device Common Name: | Dental Adhesive | | Device Classification Name: | Agent, Tooth Bonding, Resin | | Classification Panel: | Dental | nd Rinse Dental Resin Dental Class II Classification Product Code: KLE 872.3200 Adper Single Bond Plus (K962785) Indication for Use: Regulation Number: Predicated Devices: Device Class: | NanovaTM 2 Step Etch and Rinse Dental<br>Adhesive | Adper Single Bond Plus (K962785) | |----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | NanovaTM 2 Step Etch and Rinse Dental<br>Adhesive is indicated for use in: | The device is indicated for direct and<br>indirect dental bonding applications;<br>bonding veneers and root desensitization | | • All direct restorations | | | • All indirect restorations | | | • Intra-oral repairs | | | • Desensitizing/sealing of tooth structure | | | • Priming of enamel for orthodontic use | | Both products are indicated for direct bonding, indirect bonding, and desensitization. The predicate includes bonding veneers, which can be placed either with indirect bonding or direct bonding technique. Nanova" 2 Step Etch and Rinse Dental Adhesive include intra oral repairs and orthodontic applications, which are typically direct bonding. Any differences observed do not introduce any new or increased concerns of safety or effectiveness. Device Description: Nanova" 2 Step Etch and Rinse Dental Adhesive is a methacrylate based, visible-light activated, dental adhesive, the same as the predicate. This device is available in bottle or unit dose packaging, the same as the predicate. Nanova™ 2 Step Etch and Rinse Dental Adhesive contains ethanol, methacrylate resins, photoinitiator, and inorganic filler material the same as the predicate. When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photoinitiator system, a light-induced {4}------------------------------------------------ K172977 polymerization to form a hard sealant that is bonded to the prepared tooth structure. Any differences between the subject device and the predicate do not introduce any introduce any new or increased concerns about safety or effectiveness. | | Nanova™ 2 Step Etch and<br>Rinse Dental Adhesive | Adper Single Bond Plus<br>(K962785) | |-------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Composition | Ethanol, methacrylate resins,<br>photo-initiators, inorganic<br>fillers | Ethanol, methacrylate resins,<br>Silica, photo-initiators, inorganic<br>fillers | | Packaging | Bottle, Unit Dose | Bottle, Unit Dose | | Etch Time | 15s etch | 15s etch | | Cure Time | 10s light cure | 10s light cure | | Bonding | Bonds to dentin, enamel,<br>ceramic, and metal | Bonds to dentin, enamel,<br>porcelain, and metal | ## Non Clinical Performance: Non-clinical performance testing conducted is shown in the table below. Nanova" 2 Step Etch and Rinse Dental Adhesive met performance criteria for every test including: shear strength, microtensile strength, water sorption, water solubility, and degree of conversion. Non-clinical comparison testing was based on ISO 29022, ISO 4049, and internal specifications. A comparison is shown in the table below. | Property | Standard | Nanova™ 2 Step Etch and<br>Rinse Dental Adhesive | |------------------------|-------------------------|--------------------------------------------------| | Shear Bond Strength | ISO 29022:2013 | Met internal performance criteria | | Micro-Tensile Strength | Internal specifications | Met internal performance criteria | | Water Sorption | ISO 4049:2009 | Met internal performance criteria | | Water Solubility | ISO 4049:2009 | Met internal performance criteria | | Degree of Conversion | Internal specification | Met internal performance criteria | # Biocompatibility: Nanovation 2 Step Etch and Rinse Dental Adhesive completed a risk assessment covering the identification of legally marketed devices for all ingredients in the chemical composition and testing including: cytotoxicity (ISO 10993-5), irritation (ISO 10993-10), sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11). ## Clinical Performance Testing: Clinical performance data was not conducted. ## Conclusion: Nanova Biomaterials Inc. believes that Nanova" 2 Step Etch and Rinse Dental Adhesive is substantially equivalent to currently legally marketed products. Product based on comparison of similar intended use and technology together with the nonclinical performance testing. Any differences do not raise different questions of safety and effectiveness than the predicate, nor do they affect the safety or effectiveness of the subject device. These differences therefore do not render the new device NSE in comparison to the predicate.