Coating Material

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 27, 2015 Sun Medical Co., Ltd. c/o Ms. Carrie Hetrick Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701 Re: K150511 Trade/Device Name: Coating Material Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: February 26, 2015 Received: February 27, 2015 Dear Ms. Hetrick: 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. {1}------------------------------------------------ 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 (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 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), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours. Tina Kiang -S for Erin I. Keith, M.S. 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) K150511 Device Name Coating Material Indications for Use (Describe) Coating Material is a light-cured, transparent resin sealant for acrylic denture bases that produces a smooth, glossy surface finish on the denture. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 for ## Coating Material #### 1. Submission Sponsor Sun Medical Co., Ltd. 571-2, Furutaka-cho Moriyama, Shiga 524-0044 Japan Phone: 81-77-582-9978 Fax: 81-77-582-9984 Contact: Mr. Yukihito Yukimune, Pharmaceutical Affairs Department Director ### 2. Submission Correspondent Emergo 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 833.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, Regulatory Affairs Email: project.management@emergogroup.com ### 3. Date Prepared May 19, 2015 ### 4. Device Identification | Trade/Proprietary Name: | Coating Material | |----------------------------|------------------------------------------------| | Common/Usual Name: | Coating Material | | Classification Name: | Denture Relining, Repairing, or Rebasing Resin | | Classification Regulation: | 21 CFR § 872.3760 | | Product Code: | EBI | | Device Class: | Class II | | Classification Panel: | Dental | ### 5. Legally Marketed Predicate Device(s) Heraeus Kulzer, Inc., Palaseal® - K892452 #### 6. Device Description Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface {4}------------------------------------------------ provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture. ### 7. Indication for Use Statement Coating Material is a light-cured, transparent resin sealant for acrylic denture bases that produces a smooth, glossy surface finish on the denture. ### 8. Substantial Equivalence Discussion The following table compares the Coating Material to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. | Manufacturer | Sun Medical Co., Ltd. | Heraeus Kulzer, Inc. | Significant Differences | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Coating Material | Palaseal® | | | 510(k) Number | K150511 | K892452 | Not applicable | | Product Code | EBI | EBI | Same | | Regulation<br>Number | 21 CFR § 872.3760 | 21 CFR § 872.3760 | Same | | Regulation<br>Name | Denture Base Resin | Denture Base Resin | Same | | Device<br>Description | Coating Material is a light-<br>cured denture base<br>coating that is composed<br>of two liquids that are<br>mixed prior to use, and<br>then photo-polymerized<br>by a UV radiation. | Palaseal® is a light-curing,<br>transparent sealing resin<br>that bonds to any denture<br>materials, temporary<br>crowns, and bridges. The<br>patient receives an<br>aesthetically and<br>functionally comfortable<br>denture. | Similar with minor<br>variation - Both are<br>transparent, light-cured<br>resins intended to seal<br>acrylic dentures | | Indications for<br>Use | Coating Material is a light-<br>cured, transparent resin<br>sealant for acrylic denture<br>bases that produces a<br>smooth, glossy, and<br>functionally comfortable<br>denture. | Photocuring lacquer for<br>sealing dentures and<br>temporary crowns and<br>bridges based on PMMA-<br>resin. | Similar with minor<br>variation- both are a<br>coating material for<br>dentures. The predicate is<br>also intended for use in<br>temporary crowns and<br>bridges. | | Area of<br>application | - Surface sealing of<br>dentures<br>- Surface sealing of<br>dentures after<br>finishing | - Surface sealing of<br>dentures<br>- Surface sealing of<br>dentures after<br>finishing<br>- Surface sealing of<br>temporary crowns<br>and bridges | Similar with minor<br>variation - both are<br>intended for sealing<br>dentures. They differ in<br>that the Palaseal is also<br>intended to be used as a<br>surface sealant of<br>temporary crowns and<br>bridges | | Chemical<br>composition | Acrylic compounds,<br>solvent, and a photo<br>initiator | Multifunctional<br>methacrylate, methyl<br>methacrylate, and a photo<br>initiator | Similar - The devices are<br>composed of similar<br>acrylic raw materials, have<br>the same intended use<br>and technological | Table 5A - Comparison of Characteristics {5}------------------------------------------------ | Manufacturer | Sun Medical Co., Ltd. | Heraeus Kulzer, Inc. | Significant Differences | |-----------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Polymerization<br>(Curing) Method | Cured by Ultraviolet (UV)<br>radiation | Cured by Ultraviolet (UV)<br>radiation | Same | | Components | Two-Component System -<br>Liquid A and Liquid B | One-component System -<br>Denture Lacquer | Differ - The subject device<br>is a two-part liquid system<br>that requires the user to<br>mix, and the predicate is<br>one part liquid system. | | Appearance | Smooth, high gloss surface<br>with no evidence of<br>cracking or peeling after<br>being light-cured | Smooth, high gloss surface<br>with no evidence of<br>cracking or peeling after<br>being light-cured | Same | | Application | Applied with a brush or by<br>dipping into a tub | Applied with a brush | Similar - Both may be<br>applied with a brush | | Biocompatibility | ISO 10993-1, ISO 7405 | ISO 10993-1, ISO 7405 | Same | The subject and predicate devices are liguid formulations that contain acrylic compounds, solvent, and an initiator. All of the components of the Coating Material have similar to the predicate device. Coating Material requires the user to mix the two liquid components, while the predicate is a one-liquid product. The curing mechanism of the devices is polymerization of uncured acrylic monomers. This reaction is caused by a photo initiator system. The Coating Material shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device. All of the components have been used in legally marketed devices. The formulations have not been changed in ways that may adversely impact device performance. ## 9. Non-Clinical Performance Data Extensive testing has been performed on the subject denture base resin to demonstrate compliance with ISO 7405:1997 Dentistry; Preclinical evaluation of biocompatibility of medical devices used in dentistry, Test methods for dental materials. The following testing has been performed to support substantial equivalence: Biocompatibility –The biological safety of the Coating Material was evaluated in accordance with ISO 7405:2008, ISO 10993-1: 2009 and guidance document entitled Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing. Under these, for the stated indications for use, the device was classified as a permanent exposure (C), surface-contacting device in contact with mucosal membranes. The Coating Material biocompatibility was tested for the following with the final results. - Cytotoxicity (MEM Elution Test) - The Coating Material was found to be noncytotoxic, and all test method acceptance criteria were met per ISO 10993-5. - Skin Sensitisation (Guinea Pig Maximization) - Coating Material is considered to cause no sensitization under the experimental conditions of this study per ISO 10993-10. {6}------------------------------------------------ - Intracutaneous Reactivity - Coating Material caused no signs of irritation, met the requirements of the test and is classified as not irritant per ISO 10993-10. - . Subchronic Toxicity - Coating Material is considered to not cause significant systemic toxicity under the experimental conditions of this study per ISO 10993-11. - Genotoxicity (In Vitro Mammalian Chromosome Aberration Test) - Coating Material extract is considered to be non-clastogenic under the experimental conditions of this study per ISO 10993-3. - . Genotoxicity Bacterial Reverse Mutation (AMES) Test - Coating Material was considered non-mutagenic (non-genotoxic and non-clastogenic) under the experimental conditions of this study per ISO 10993-3. Performance Bench Testing - It is confirmed that the Coating Material conforms to the required specifications and is suitable for its intended use. Performance testing includes: - . Coating applicability - . The properties of the coated surface Risk Management – Risk Analysis was conducted according to ISO 14971, and the outcomes of these risks are considered acceptable, and that all potential risks have been mitigated to the lowest form. The Coating Material meets all the requirements for the overall design, performance, and biocompatibility, confirming that the output meets the design inputs and specifications. The Coating Material passed all testing stated above as shown by the acceptable results obtained. The Coating Material complies with the applicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards. ### 10. Clinical Performance Data There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years and there are no adverse reactions. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. ### 11. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The Coating Material has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate devices. Coating Material, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices in terms of intended use, design, materials, and function.