Acrylic Block

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with no facial features. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 14, 2015 Sun Medical Co. Ltd. c/o Carrie Hetrick, D.D.S. Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701 Re: K143265 Trade/Device Name: Acrylic Block Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: II Product Code: EBI Dated: March 6, 2015 Received: March 10, 2015 Dear Dr. 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}------------------------------------------------ Page 2 - Carrie Hetrick, D.D.S. 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) K143265 Device Name Acrylic Block Indications for Use (Describe) Acrylic Block is a cured base acrylic resin that is indicated for use to fabricate a 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 ## Acrylic Block #### 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 Group 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 April 14, 2015 ### 4. Device Identification | Trade/Proprietary Name: | Acrylic Block | |----------------------------|------------------------------------------------| | Common/Usual Name: | Denture Base Resin | | 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) Yamahachi Dental Manufacturing Co., Yamahachi Denture Base Resins- K131036 ### 6. Device Description The Acrylic Block is a solid block of an acrylic polymer block that includes small quantities of color pigments. This Acrylic Block is a high polymer material made from quality poly methyl methacrylate. Poly (methyl methacrylate) is commonly used for thermopolymerizable {4}------------------------------------------------ acrylic resin denture bases because of its properties, including color and durability. In vitro tests have also shown its biocompatibility and enhancement of flexural behavior properties. To fabricate the denture base, the Acrylic Block is milling machine utilizing the CAM data. After a 3D denture image is structured using the 3D CAD software, the artificial teeth are factored out, and a 3D denture base image is obtained. The Acrylic Block is then milled to the shape of the denture base. The artificial teeth are then bonded to the milled denture base using a bonding material and polished. ## 7. Indication for Use Statement Acrylic Block is a cured base acrylic resin that is indicated for use to fabricate a denture. ### 8. Substantial Equivalence Discussion The following table compares the Acrylic Block 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. | Yamahachi Dental Manufacturing<br>Co. | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Acrylic Block | Yamahachi Denture Base<br>Resins | | 510(k) Number | K143265 | K131036 | | Product Code | EBI | EBI | | Regulation Number | 21 CFR § 872.3760 | 21 CFR § 872.3760 | | Regulation Name | Denture Base Resin | Denture Base Resin | | Device Description | It is used for creation of a denture<br>base with a computer-aided-<br>design and computer-aided-<br>manufacturing unit. | Traditional heat-cure and<br>microwave-cure acrylic resign for<br>total or partial denture base and<br>for removable prosthesis | | Indications for Use | Acrylic Block is a cured base acrylic<br>resin that is indicated for use to<br>fabricate a denture. | Yamahachi Denture Base Resins<br>is a system of heat- and self-cure<br>acrylic polymers intended for<br>fabrication or repair of the denture<br>base. | | Composition of Material - | Block made by Methyl | Polymer powder and monomer | | the chemical composition of<br>the device | methacrylate (MMA) monomer | liquid | | Polymerization (Curing)<br>Method | Acrylic Blocks polymerization is<br>completed by heat curing method<br>at 20° C to 80° C. | Water Bath: Immerse flask in<br>water & slowly raise to boiling<br>over 30 min, boil 30-40 min, air<br>cool 30 min (Basis & Basis HI);<br>Curing: Immerse flask in boiling<br>water 30 min (Basis TC) | | Components | PMMA, initiator, pigments | Powder: PMMA, MMA (Basis Hi),<br>Initiator, pigments<br>Liquid:-MMA, Crosslinker, activator<br>(Basis TC) | | Standards of Conformity | ISO 9001:2007, ISO 13485:2002 | ISO 9001:2007, ISO 13485:2002 | | | Table 5A - Comparison of Characteristics | | | |--|------------------------------------------|--|--| |--|------------------------------------------|--|--| {5}------------------------------------------------ | Manufacturer | Sun Medical Co., Ltd. | Yamahachi Dental Manufacturing Co. | |---------------------|-------------------------------|------------------------------------| | Trade Name | Acrylic Block | Yamahachi Denture Base Resins | | | ISO 14971 | ISO 14971 | | Biocompatibility | ISO 10993-1, ISO 7405 | ISO 10993-1, ISO 7405 | | Physical Properties | ISO 20795-1, ANSI/ADA 12:2002 | ISO 20795-1 | ### 9. Non-Clinical Performance Data Extensive testing has been performed on the subject denture base resin to demonstrate compliance with EN ISO 7405:1997 Dentistry; Preclinical evaluation of biocompatibility of medical devices used in dentistry, Test methods for dental materials; and EN ISO 1567:1995 Denture Base Polymers. The following testing has been performed to support substantial equivalence: Biocompatibility -The biocompatibility of the Acrylic Block 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 Sun Medical Acrylic Block biocompatibility was tested for the following with the final results. - . Cytotoxicity (MEM Elution Test) – The Acrylic Block was found to be non-cytotoxic and all test method acceptance criteria were met per ISO 10993-5, JIS T 6001, Yakushokukihatsu No. 0301-20. - . Skin Sensitisation (Guinea Pig Maximization) - Acrylic Block is considered to cause no sensitization under the experimental conditions of this study per ISO 10993-10, IIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20. - Intracutaneous Reactivity - Acrylic Block caused no signs of irritation, met the requirements of the test, and is classified as not irritant per ISO 10993-10, JIS T 6001, and Yakushokukihatsu No. 0301-20. - . Subchronic Toxicity - Acrylic Block is considered to not cause significant systemic toxicity under the experimental conditions of this study per ISO 10993-11, JIS T 6001, Yakushokukihatsu No. 0301-1. And Yakushokukihatsu No. 0301-20. - . Genotoxicity (In Vitro Mammalian Chromosome Aberration Test) - Acrylic Block extract is considered to be non-clastogenic under the experimental conditions of this study per ISO 10993-3, JIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20. - . Genotoxicity Bacterial Reverse Mutation (AMES) Test - Acrylic Block was considered non-mutagenic (non-genotoxic and non-clastogenic) under the experimental conditions of this study per ISO 10993-3, JJST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20. Mechanical Testing – Performance testing of the Acrylic Block included testing for denture base polymers and copolymers in ISO 20795-1, Dentistry -- Base polymers -- Part 1: Denture {6}------------------------------------------------ base polymers, ISO 22112 Dentistry - Artificial teeth for dental prostheses, and ANSI/ADA Specification No. 12 - Denture Base Polymers. Performance testing was conducted to evaluate the mechanical properties of the Acrylic Block. Specimens for each test were made according to the ADA/ANSI Specification No. 12: 2002 (Reaffirmed 2008) Denture Base Polymers to evaluate the subject devices flexural and tensile strengths, and fracture toughness. The subject device was also examined the ADA specification for surface characteristics, color, translucency, freedom from porosity, flexural strength, flexural modulus, residual methyl methacrylate monomer, sorption and solubility. It was concluded that the Acrylic Block met all acceptance criterion and hence are substantially equivalent to Yamahachi Denture Base Resins in terms of mechanical properties. It was also concluded that the Sun Medical Acrylic Block show a substantially similar performance other predicate denture base resins during non-clinical bench testing. 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. PMMA resin continues to be the universal, versatile polymer in prosthetic dentistry. The Acrylic Block has the same biological performance as predict PMMA resins. As part of demonstrating that the Acrylic Block is substantially equivalent to predicate devices that are subject to this 510(k) submission, Sun Medical Co., Ltd. completed a number of tests. The Acrylic Block meets all the requirements for overall design and biocompatibility confirms that the output meets the design inputs and specifications. The Acrylic Block passed all testing stated above as shown by the acceptable results obtained 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. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device. The Acrylic Block has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate devices. The Acrylic Block, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices in terms of intended use, design, materials, and function.