TOKUYAMA UNIVERSAL BOND

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. November 28, 2017 Tokuyama Dental Corporation % Keith Barritt Attorney Fish & Richardson 901 15th Street, N.W., Suite 700 Washington, District of Columbia 20005 Re: K171226 Trade/Device Name: TOKUYAMA UNIVERSAL BOND Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: October 23, 2017 Received: October 24, 2017 Dear Keith Barritt: 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 -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) K171226 Device Name TOKUYAMA UNIVERSAL BOND Indications for Use (Describe) The TOKUYAMA UNIVERSAL BOND is indicated for: - Direct anterior and posterior restorations with light-curing, and self-curing composite materials - Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without an additional primer - Cementation of indirect restorations and veners when combined with light-cure, and self-curing resin cements - Bonding of core build-ups made of core build-up materials - Bonding of denture resin to metal base, clasp or attachment - Repair of denture with metal base, clasp or attachment - Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns | 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 Tokuyama Dental Corporation TOKUYAMA UNIVERSAL BOND ### Submitter's Name and Address ### (i) 510(k) Submitter Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: 011-81-3-3835-2261 ### (ii) 510(k) Submitter Contact Keith A. Barritt Fish & Richardson P.C. 901 15th Street, N.W., Suite 700 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 barritt@fr.com Email: ### (iii) Preparation Date November 24, 2017 ### Name of Device | Trade or Proprietary Name: | TOKUYAMA UNIVERSAL BOND | |----------------------------|-----------------------------| | Common Name: | self-cured dental adhesive | | Classification Name: | agent, tooth bonding, resin | | Product Code: | KLE | | Regulation: | 21 CFR 872.3200 | {4}------------------------------------------------ ### Predicate Devices Primary Predicate: ADHESIVE EXL-759 (K#110302) Reference Predicates: FUTURABOND UNIVERSAL (K#130486), ALLOY PRIMER (K#012436), and ESTECEM (K#150727). ### Device Description The TOKUYAMA UNIVERSAL BOND device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch, and total-etch techniques. The TOKUYAMA UNIVERSAL BOND device is fully compatible with light-cured. self-cured, and dual-cured composite materials. Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrate by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends. The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler. The device is depicted below: {5}------------------------------------------------ ### K#171226 Image /page/5/Picture/1 description: The image shows a dental adhesive kit with several components. The kit includes an outer box, two bottles labeled "Bond A" and "Bond B", a mixing well, and a disposable mixing well. Additionally, there is a disposable applicator included in the kit. The adhesive kit appears to be a comprehensive set for dental bonding procedures. The TOKUYAMA UNIVERSAL BOND device does not come sterilized and is not intended to be sterilized prior to use. ### Intended Use/Indications for Use The TOKUYAMA UNIVERSAL BOND is indicated for: - Direct anterior and posterior restorations with light-curing, dual-curing, and self-curing composite materials - Intraoral repair of composite restorations, porcelain fused to metal, metal, and all-ceramic restorations without an additional primer - Cementation of indirect restorations and veneers when combined with light-cure, dual-cure, and self-curing resin cements - Bonding of core build-ups made of core build-up materials - Bonding of denture resin to metal base, clasp or attachment - Repair of denture with metal base, clasp or attachment - Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns {6}------------------------------------------------ ### Technological Characteristics The TOKUYAMA UNIVERSAL BOND device has the same basic technological characteristics in terms of design, material, and chemical composition as the devices identified above. The TOKUYAMA UNIVERSAL BOND device does not have an energy source. Although the chemical compositions are not identical, the material properties, principles of operation, and performance characteristics of the TOKUYAMA UNIVERSAL BOND device are comparable to the previously authorized devices identified above, as demonstrated in part by the non-clinical performance bench testing described below. A comprehensive chart comparing the devices appears below. {7}------------------------------------------------ | 226 | | |--------|--| | I<br>L | | | I | | | K# | | | Device name | Manufacturer<br>510(k) No.<br>Classification<br>name | Subject device<br>TOKUYAMA UNIVERSAL<br>BOND<br>Tokuyama Dental Corporation<br>K171226<br>Agent, Tooth Bonding, Resin | Primary predicate<br>Adhesive EXL 759<br>3M ESPE AG<br>K110302<br>Agent, Tooth Bonding, Resin | Reference<br>Futurabond Universal<br>VOCO GmbH<br>K130486<br>Agent, Tooth Bonding, Resin | Reference<br>Alloy Primer<br>Kuraray Noritake Dental Inc.<br>K012436<br>Agent, Tooth Bonding, Resin | Reference<br>Estecem<br>Tokuyama Dental Corporation<br>K150727<br>Cement, Dental | Difference | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------| | Indications for Use | The TOKUYAMA UNIVERSAL<br>BOND is indicated for:<br><br>Direct anterior and posterior<br>restorations with light-curing,<br>dual-curing, and self-curing<br>composite materials<br>Intraoral repair of composite<br>restorations, porcelain fused to<br>metal, metal, and all-ceramic<br>restorations without an<br>additional primer<br>Cementation of indirect<br>restorations and veneers when<br>combined with light-cure, dual-<br>cure, and self-curing resin<br>cements<br>Bonding of core build-ups made<br>of core build-up materials<br>Bonding of denture resin to<br>metal base, clasp or attachment<br>Repair of denture with metal<br>base, clasp or attachment<br>Bonding of opaque resin to a<br>metal base in the fabrication of<br>resin-faced crowns | All classes of fillings (according<br>to Black) with light-curing<br>composite or compomer filling<br>materials<br>Cementation of indirect<br>restorations (inlays, onlays,<br>crowns, bridges, veneers) of<br>composite, compomer, cramic,<br>and metal when combined with<br>Suglue-10 Adhesive Resin<br>Cement, manufactured by 3M<br>ESPE<br>Cementation of veneers when<br>combined with RelyX Veneer<br>Cement, manufactured by 3M<br>ESPE<br>Bonding of core build-ups made<br>of light-curing composite or core<br>build-up materials<br>Bonding of dual-cure cements<br>and core build-up materials and<br>self-cure composites when<br>combined with Activator EXL<br>760<br>Repair of composite or<br>compomer fillings<br>Intraoral repair of composite<br>restorations, porcelain fused to<br>metal, and all-ceramic<br>restorations without extra<br>primer<br>Root surface desensitization | Futurabond Universal is<br>intended for use as:<br><br>Adhesive for direct restorations<br>of all classes of cavities using<br>light-curing composite/<br>compomer/Ormocer materials<br>with a methacrylate base<br>Adhesive for core build-ups<br>made of light-curing composite<br>materials<br>Adhesive for indirect<br>restorations with light-curing<br>luting composites<br>Intraoral repair of composite,<br>compomer or Ormocer<br>rstorations, ceramic veneers<br>and all ceramic restorations<br>without an additional primer<br>Treatment of hypersensitive<br>tooth necks<br>Protective varnish for glass<br>ionomer cement restorations<br>Sealing of cavities prior to<br>amalgam restorations<br>Sealing of cavities and core<br>preparations prior to the<br>temporary luting of indirect<br>restorations<br>Adhesive for direct self-curing<br>or dual-curing composite<br>restorations of all classes of | ALLOY PRIMER is indicated<br>for the following applications:<br><br>1) Adhesion of metal posts,<br>metal inlays, onlays, crown<br>and bridges<br>2) Repair of fractures resin-<br>based facing crowns and<br>porcelain-fused metal<br>crowns<br>3) Fabrication of removable<br>dentures with metal base,<br>clasp or attachment. Repair<br>of dentures | The ESTECEM device is an<br>adhesive resin cement for the<br>cementation of crowns, bridges,<br>inlays, and onlays made of<br>glass/oxide ceramics (porcelain,<br>zirconia and alumina),<br>metals/alloys (precious and<br>non-precious) and resin<br>materials including inorganic<br>filler (composite materials).<br>The ESTECEM device is<br>indicated for:<br><br>Repair of fractured porcelain<br>fused to metal crowns and all<br>ceramic restorations<br>Cementation of veneers<br>Cementation of adhesion<br>bridges<br>Cementation of metal or resin<br>cores, metal or glass-fiber posts | The Indications<br>for Use of the<br>subject device is<br>within that of the<br>predicate and the<br>reference devices. | | # Comparison of TOKUYAMA UNIVERSAL BOND device with the primary predicate and the reference devices {8}------------------------------------------------ {9}------------------------------------------------ | Device name | Subject device | Primary predicate | Futurabond Universal | Reference | Estecem | Difference | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | TOKUYAMA UNIVERSAL BOND | Tokuyama Dental Corporation | Adhesive EXL 759 | VOCO GmbH | Alloy Primer | | | | | | | | Kuraray Noritake Dental Inc. | | | | | K171226 | 3M ESPE AG | K130486 | K012436 | Tokuyama Dental Corporation | | | Manufacturer<br>10(k) No.<br>Material | Phosphate monomer<br>Bis-GMA<br>TEGDMA<br>HEMA<br>Thiouracil monomer<br>(functioning as adhesion to metal)<br>Silane coupling agent<br>Peroxide<br>Borate catalyst (initiator)<br>Acetone<br>Isopropanol<br>Water | Phosphate monomer<br>Methacrylate-modified<br>polyalkenoic acid copolymer<br>Dimethacrylate resins<br>HEMA<br>Silane<br>Initiators<br>Ethanol<br>Water | Acidic monomers<br>Methacrylates<br>Catalysts<br>Initiators<br>Ethanol<br>Water | Phosphate monomer<br>VBATDT (functioning as adhesion to metal)<br>Acetone | (Adhesive components such as Estelink and Tokuyama Universal Primer:)<br>K150727<br>Phosphate monomer<br>Carboxylic acid monomer<br>Bis-GMA<br>TEGDMA<br>HEMA<br>UDMA<br>Thiouracil monomer<br>(functioning as adhesion to metal)<br>Silane coupling agent<br>Peroxide<br>Borate catalyst (initiator)<br>Acetone<br>Isopropanol<br>Ethanol<br>Water | The subject device contains a phosphate monomer,<br>methacrylic monomer, adhesive compound to prosthetic materials, initiator and solvent as with the predicate and the reference devices. The biocompatibility of the device has been thoroughly evaluated and performance tested. | | Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | K#171226 # Physical Property Testing (1) Tensile bond strength to tooth structure | | Tifferen. | | | | |-----------------------|---------------------------|-----------------------------------------|------------------------------------------|--| | | Estecem *** | 1<br>I | -<br>I | | | Leference | uturabond Universa | L LI<br>I | 1<br>I | | | Primary predicat<br>0 | 759<br>Adhesive EXL | ڪ ا<br>I | 1<br>I | | | Subject device | TOKUYAMA UNIVERSA<br>BOND | > 12 | L V<br>> 10 | | | | Evaluation item | 'ensile bond strength to enamel * [MPa] | 'ensile bond strength to dentin ** [MPa] | | In-house specification is more than 12 MP * {10}------------------------------------------------ ## K#171226 *** *** ** in-house specification is more than 10 MPa. The component tested was "Estelink" which was a component in the device for adhesion to tooth struct Tensile bond strength to meta (ढ | Evaluation item | Subject device | Primary predicate | Reference | Difference | |--------------------------------------------------------------------------------------|-------------------------|-------------------|--------------|------------| | Tensile bond strength to metal * [MPa]<br>In-house specification is more than 12 MPa | TOKUYAMA UNIVERSAL BOND | Adhesive EXL 759 | Alloy Primer | Estecem ** | | > 12 | > 12 | > 12 | > 12 | > 12 | ** ouse specification is more than 12 ML a. component tested was "Tokuyama Universal Primer" which was a component in the device for adhesion mater (3) Tensile bond strength to ceramics and resin material including inorganic f | Evaluation item | Subject device | Primary predicate | Reference | Difference | |----------------------------------------------------------------------------|-------------------------|-------------------|------------|------------| | Tensile bond strength to porcelain * [MPa] | TOKUYAMA UNIVERSAL BOND | Adhesive EXL 759 | Estecem ** | ≥ 10 | | Tensile bond strength to zirconia * [MPa] | TOKUYAMA UNIVERSAL BOND | Adhesive EXL 759 | Estecem ** | ≥ 10 | | Tensile bond strength to resin material including inorganic filler * [MPa] | TOKUYAMA UNIVERSAL BOND | Adhesive EXL 759 | Estecem ** | ≥ 10 | ** In house specification is more than 10 MPa. The component tested was "Tokuyama Universal Primer" which was a component in the device for adhesion to prosthetic materia {11}------------------------------------------------ ### Non-clinical Testing Non-clinical testing of the following physical properties was conducted on the TOKUYAMA UNIVERSAL BOND device. Tensile bond strength to enamel: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. Tensile bond strength to dentin: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. Tensile bond strength to metal: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. Tensile bond strength to porcelain: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. Tensile bond strength to zirconia: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. Tensile bond strength to resin material including inorganic filler: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. The working time of the device was evaluated by confirming whether the device was cured after 90 seconds. The paintability of the device was evaluated by determining if an even film was formed. The appearance of the device was evaluated via visual inspection. The precise formulation of the device is confidential. Substantial biocompatibility testing was conducted in accordance with ISO 10993-1:2009 and ISO 7405:2008. ### Clinical Testing There were no clinical tests performed for the TOKUYAMA UNIVERSAL BOND device. ### Conclusions from Testing Based on the non-clinical testing conducted of the physical properties and the biocompatibility testing of the TOKUYAMA UNIVERSAL BOND device, it is concluded that the TOKUYAMA UNIVERSAL BOND device is substantially equivalent to the primary predicate and reference devices identified above.