Who is the manufacturer of TOKUYAMA UNIVERSAL BOND?

Tokuyama Dental Corporation filed the 510(k) submission for TOKUYAMA UNIVERSAL BOND (K171226).

What is the FDA product code for TOKUYAMA UNIVERSAL BOND?

KLE. It is classified under 21 CFR 872.3200 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TOKUYAMA UNIVERSAL BOND?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TOKUYAMA UNIVERSAL BOND?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TOKUYAMA UNIVERSAL BOND

K171226 · Tokuyama Dental Corporation · KLE · Nov 28, 2017 · Dental

Device Facts

Record ID	K171226
Device Name	TOKUYAMA UNIVERSAL BOND
Applicant	Tokuyama Dental Corporation
Product Code	KLE · Dental
Decision Date	Nov 28, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3200
Device Class	Class 2

Intended 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

Device Story

Two-component self-cured dental adhesive system; used for direct and indirect restorations; compatible with light-cured, self-cured, and dual-cured composites. Bond A and Bond B mixed prior to application; polymerization initiated upon mixing; applied to adherends and air-dried to form a cured adhesive layer. Used in dental clinics by dentists. Enhances bond strength of resin materials to tooth structure and restorative materials (glass-ceramics, oxide-ceramics, metals, resin). Improves clinical outcomes for restorations and repairs.

Clinical Evidence

No clinical data. Bench testing only. Physical property testing (tensile bond strength to enamel, dentin, metal, porcelain, zirconia, and resin) conducted per ISO/TS 11405:2015. All results met in-house specifications (≥12 MPa for tooth/metal, ≥10 MPa for ceramics/resin). Biocompatibility testing performed per ISO 10993-1:2009 and ISO 7405:2008.

Technological Characteristics

Two-component self-cured adhesive system. Materials: phosphate monomer, Bis-GMA, TEGDMA, HEMA, thiouracil monomer, silane coupling agent, peroxide, borate catalyst, acetone, isopropanol, water. No energy source. Non-sterile. Manual mixing and application.

Indications for Use

Indicated for dental patients requiring direct/indirect restorations, intraoral repairs of composite/ceramic/metal restorations, cementation of veneers/indirect restorations, core build-ups, and denture repairs/bonding.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

ADHESIVE EXL-759 (K110302)

Reference Devices

FUTURABOND UNIVERSAL (K130486)
ALLOY PRIMER (K012436)
ESTECEM (K150727)

Related Devices

K203760 — Tokuyama Universal Bond II · Tokuyama Dental Corporation · May 25, 2021
K011908 — OPTIBOND SOLO PLUS 3 · Kerr Dental Materials Center · Sep 6, 2001
K982394 — PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM · Dentsply Intl. · Sep 21, 1998
K062382 — CLEARFIL DC BOND · Kuraray Medical, Inc. · Sep 27, 2006
K070538 — XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE · Dentsply Intl. · Mar 14, 2007

Submission Summary (Full Text)

{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 L | | | I | | | K# | | | Device name | Manufacturer 510(k) No. Classification name | Subject device TOKUYAMA UNIVERSAL BOND Tokuyama Dental Corporation K171226 Agent, Tooth Bonding, Resin | Primary predicate Adhesive EXL 759 3M ESPE AG K110302 Agent, Tooth Bonding, Resin | Reference Futurabond Universal VOCO GmbH K130486 Agent, Tooth Bonding, Resin | Reference Alloy Primer Kuraray Noritake Dental Inc. K012436 Agent, Tooth Bonding, Resin | Reference Estecem Tokuyama Dental Corporation K150727 Cement, Dental | Difference | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------| | 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 | All classes of fillings (according to Black) with light-curing composite or compomer filling materials Cementation of indirect restorations (inlays, onlays, crowns, bridges, veneers) of composite, compomer, cramic, and metal when combined with Suglue-10 Adhesive Resin Cement, manufactured by 3M ESPE Cementation of veneers when combined with RelyX Veneer Cement, manufactured by 3M ESPE Bonding of core build-ups made of light-curing composite or core build-up materials Bonding of dual-cure cements and core build-up materials and self-cure composites when combined with Activator EXL 760 Repair of composite or compomer fillings Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer Root surface desensitization | Futurabond Universal is intended for use as: Adhesive for direct restorations of all classes of cavities using light-curing composite/ compomer/Ormocer materials with a methacrylate base Adhesive for core build-ups made of light-curing composite materials Adhesive for indirect restorations with light-curing luting composites Intraoral repair of composite, compomer or Ormocer rstorations, ceramic veneers and all ceramic restorations without an additional primer Treatment of hypersensitive tooth necks Protective varnish for glass ionomer cement restorations Sealing of cavities prior to amalgam restorations Sealing of cavities and core preparations prior to the temporary luting of indirect restorations Adhesive for direct self-curing or dual-curing composite restorations of all classes of | ALLOY PRIMER is indicated for the following applications: 1) Adhesion of metal posts, metal inlays, onlays, crown and bridges 2) Repair of fractures resin- based facing crowns and porcelain-fused metal crowns 3) Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures | The ESTECEM device is an adhesive resin cement for the cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious and non-precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for: Repair of fractured porcelain fused to metal crowns and all ceramic restorations Cementation of veneers Cementation of adhesion bridges Cementation of metal or resin cores, metal or glass-fiber posts | The Indications for Use of the subject device is within that of the predicate and the 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 10(k) No. Material | Phosphate monomer Bis-GMA TEGDMA HEMA Thiouracil monomer (functioning as adhesion to metal) Silane coupling agent Peroxide Borate catalyst (initiator) Acetone Isopropanol Water | Phosphate monomer Methacrylate-modified polyalkenoic acid copolymer Dimethacrylate resins HEMA Silane Initiators Ethanol Water | Acidic monomers Methacrylates Catalysts Initiators Ethanol Water | Phosphate monomer VBATDT (functioning as adhesion to metal) Acetone | (Adhesive components such as Estelink and Tokuyama Universal Primer:) K150727 Phosphate monomer Carboxylic acid monomer Bis-GMA TEGDMA HEMA UDMA Thiouracil monomer (functioning as adhesion to metal) Silane coupling agent Peroxide Borate catalyst (initiator) Acetone Isopropanol Ethanol Water | The subject device contains a phosphate monomer, 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 I | - I | | | Leference | uturabond Universa | L LI I | 1 I | | | Primary predicat 0 | 759 Adhesive EXL | ڪ ا I | 1 I | | | Subject device | TOKUYAMA UNIVERSA BOND | > 12 | L V > 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] 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.