Who is the manufacturer of Tokuyama Universal Bond II?

Tokuyama Dental Corporation filed the 510(k) submission for Tokuyama Universal Bond II (K203760).

What is the FDA product code for Tokuyama Universal Bond II?

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 II?

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

What are the predicate devices for Tokuyama Universal Bond II?

TOKUYAMA UNIVERSAL BOND (K171226).

Who can help prepare an FDA 510(k) submission like Tokuyama Universal Bond II?

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 II

K203760 · Tokuyama Dental Corporation · KLE · May 25, 2021 · Dental

Device Facts

Record ID	K203760
Device Name	Tokuyama Universal Bond II
Applicant	Tokuyama Dental Corporation
Product Code	KLE · Dental
Decision Date	May 25, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3200
Device Class	Class 2

Intended Use

The TOKUYAMA UNIVERSAL BOND II 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; consists of Bond A and Bond B in separate bottles. Polymerization reaction initiates upon mixing; applied to adherends and air-dried to form a cured adhesive layer. Enhances bond strength of resin materials to tooth structure (enamel/dentin) and indirect restorative materials (glass-ceramics, zirconia, alumina, metals). Used in dental clinics by dentists for direct/indirect restorations and repairs. Benefits include universal compatibility with light-cure, dual-cure, and self-cure composites/cements, eliminating need for additional primers in many repair scenarios.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing of tensile bond strength to enamel, dentin, metal, porcelain, zirconia, and resin materials per ISO/TS 11405:2015, and biocompatibility testing per ISO 10993-1:2009.

Technological Characteristics

Two-component self-cured adhesive system. Contains phosphoric acid monomer, Bis-GMA, TEGDMA, HEMA, MTU-6, silane coupling agent, peroxide, borate catalyst, acetone, ethanol, and water. Non-sterile. No energy source. Performance specifications verified via ISO/TS 11405:2015.

Indications for Use

Indicated for direct anterior/posterior restorations, intraoral repair of composite/ceramic/metal restorations, cementation of indirect restorations/veneers, bonding of core build-ups, and denture resin bonding/repair. For use by dental professionals.

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

TOKUYAMA UNIVERSAL BOND (K171226)

Reference Devices

TOKUYAMA ONE-UP BOND F (K993917)
TOKUYAMA BOND FORCE (K070215)
ESTECEM Tokuyama Universal Primer (K150727)
Scotchbond Universal (K110302)

Related Devices

K171226 — TOKUYAMA UNIVERSAL BOND · Tokuyama Dental Corporation · Nov 28, 2017
K151619 — Prime&Bond Elect Universal Dental Adhesive · Dentsply International, Inc. · Oct 30, 2015
K982394 — PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM · Dentsply Intl. · Sep 21, 1998
K260682 — Bond-PR Universal Adhesive · Premier Dental Products Company · Mar 3, 2026
K011908 — OPTIBOND SOLO PLUS 3 · Kerr Dental Materials Center · Sep 6, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 25, 2021 Tokuyama Dental Corporation % Keith Barritt Principal Fish & Richardson, P.C. 1000 Maine Avenue, S.W., Suite 1000 Washington, District of Columbia 20024 Re: K203760 Trade/Device Name: Tokuyama Universal Bond II Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: March 23, 2021 Received: March 25, 2021 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | 510(k) Number (if known) | K203760 | | | Device Name | TOKUYAMA UNIVERSAL BOND II | | | Indications for Use (Describe) | | | | | The TOKUYAMA UNIVERSAL BOND II 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 | | Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| 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](mailto: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." | FORM FDA 3881 (7/17) | Page 1 of 1 | |----------------------|-------------| |----------------------|-------------| 26 {3}------------------------------------------------ # 510(k) SUMMARY- K203760 Tokuyama Dental Corporation TOKUYAMA UNIVERSAL BOND II # 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. 1000 Maine Avenue, S.W., Suite 1000 Washington, DC 20024 Phone: (202) 626-6433 Facsimile: (202) 783-2331 barritt@fr.com Email: ## (iii) Preparation Date December 17, 2020 # Name of Device | Trade or Proprietary Name: | TOKUYAMA UNIVERSAL BOND II | |----------------------------|-----------------------------| | Common Name: | self-cured dental adhesive | | Classification Name: | agent, tooth bonding, resin | | Product Code: | KLE | | Regulation: | 21 CFR 872.3200 | {4}------------------------------------------------ ## Predicate Devices The TOKUYAMA UNIVERSAL BOND II device (K#203760) is substantially equivalent to Tokuyama's own TOKUYAMA UNIVERSAL BOND device (K#171226). Reference devices to help establish the biocompatibility of a few ingredients are the TOKUYAMA ONE-UP BOND F (K#993917), TOKUYAMA BOND FORCE (K#\$070215), and ESTECEM Tokuyama Universal Primer (K#150727). The Scotchbond Universal device (K#110302) is also used as a reference device for performance specifications. ## Device Description The TOKUYAMA UNIVERSAL BOND II 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. As a universal adhesive, TOKUYAMA UNIVERSAL BOND II has been designed to be fully compatible with light-cured, self-cured and dual-cured composite materials. TOKUYAMA UNIVERSAL BOND II contains phosphoric acid monomer, bisphenol A di(2-hydroxy propoxy) dimethacrylate (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), 2-Hydroxyethyl methacrylate (HEMA), MTU-6 (thiouracil monomer), silane coupling agent, peroxide, borate catalyst, acetone, ethanol and purified water. 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 concentrated 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 TOKUYAMA UNIVERSAL BOND device does not come sterilized and is not intended to be sterilized prior to use. {5}------------------------------------------------ The entire device is depicted below: Image /page/5/Picture/1 description: The image shows a dental adhesive kit on a gray surface. The kit includes an outer box labeled "Universal Bond II", two bottles labeled "Bond A" and "Bond B", a disposable applicator, and a disposable mixing well. The outer box is white with blue accents, and the bottles are red and green respectively. The disposable applicator is a clear plastic tube containing several pink applicators, and the mixing well is a small, clear plastic container. Image /page/5/Picture/2 description: The image shows two glass bottles with white caps, labeled "Bond A" and "Bond B". The bottle labeled "Bond A" contains a yellow liquid, filling approximately half of the bottle. The bottle labeled "Bond B" contains a blue liquid, also filling about half of the bottle. Appearance of Bond A and B liquid {6}------------------------------------------------ ## Intended Use/Indications for Use #### The TOKUYAMA UNIVERSAL BOND II 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 #### Technological Characteristics The TOKUYAMA UNIVERSAL BOND II device has the same basic technological characteristics in terms of design, material, and chemical composition as the devices identified above. The TOKUYAMA UNIVERSAL BOND II 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 II 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}------------------------------------------------ # Comparison of TOKUYAMA UNIVERSAL BOND II device with the primary predicate and reference devices | | Subject device | Primary predicate | Reference | Difference | | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | TOKUYAMA UNIVERSAL BOND II | TOKUYAMA UNIVERSAL BOND | Scotchbond Universal (Adhesive EXL 759) 1) | | | | Manufacturer | Tokuyama Dental Corporation | Tokuyama Dental Corporation | 3M ESPE AG | - | | | 510(k) No. | K203760 | K171226 | K1103022) | | | | Health Canada licence No. | | 100487 | 87883 | | | | Classification name | Agent, Tooth Bonding, Resin | Agent, Tooth Bonding, Resin | Agent, Tooth Bonding, Resin | - | | | Indications for Use | -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 | 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 when combined with RelyX Ultimate Adhesive Resin Cement -Cementation of veneers when combined with RelyX Veneer Cement -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 Scotchbond Universal DCA -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 -Sealing of cavities prior to cementation of amalgam restorations -Sealing of cavities and preparation of tooth stumps prior to temporary cementation of indirect restorations -Bonding of fissure sealants -Protective varnish for glass ionomer fillings | Similar The Indications for Use of subject device is within that of the predicate and the reference devices. | | | Component | Consisting of Bond A and Bond B in separate bottles | Consisting of Bond A and Bond B in separate bottles | Bottle or unit-dose | Similar The subject device uses a bottle that is slightly different from the one used for the predicate device. | | | Principle of operation | | The device functions as an adhesive layer for enhancing an adhesiveness of polymerizable resin to adherends, and is used by applying on the surface of adherends. | The device functions as an adhesive layer for enhancing an adhesiveness of polymerizable resin to adherends, and is used by applying on the surface of adherends. | The device functions as an adhesive layer for enhancing an adhesiveness of polymerizable resin to adherends, and is used by applying on the surface of adherends. | Similar | | Material 3) | | - Phosphoric acid monomer - Bisphenol A di(2-hydroxy propoxy) dimethacrylate (Bis-GMA) - Triethylene glycol dimethacrylate (TEGDMA) - 2-Hydroxyethyl methacrylate (HEMA) - MTU-6 (thiouracil monomer) - Silane coupling agent - Peroxide - Borate catalyst - Acetone - Etanol - Water | - Phosphoric acid monomer - Bisphenol A di(2-hydroxy propoxy) dimethacrylate (Bis-GMA) - Triethylene glycol dimethacrylate (TEGDMA) - 2-Hydroxyethyl methacrylate (HEMA) - MTU-6 (thiouracil monomer) - Silane coupling agent - Peroxide - Borate catalyst - Acetone - Isopropnanol - Water | -2-HYDROXYETHYL METHACRYLATE - BISPHENOL A DIGLYCIDYL ETHER DIMETHACRYLATE (BIS-GMA) -2-PROPENOIC ACID, 2- METHYL-, REACTION PRODUCTS WITH 1,10- DECANEDIOL AND PHOSPHOROUS OXIDE (Phosphoric acid monomer) - ETHANOL -2-PROPENOIC ACID, 2- METHYL-, 3- (TRIMETHOXYSILYL)PR OPYL ESTER, REACTION PRODUCTS WITH VITREOUS SILICA -COPOLYMER OF ACRYLIC AND ITACONIC ACID -CAMPHORQUINONE - DIMETHYLAMINO BENZOAT(-4) -(DIMETHYLAMINO)ETHY L METHACRYLATE | Similar The subject device contains a phosphate monomer, methacrylic monomer, adhesive compound to prosthetic materials, initiator, catalyst and solvent as with the predicate device. | | | Enamel [MPa] | ≥ 12 | ≥ 12 | - | Similar | | | Dentin [MPa] | ≥ 10 | ≥ 10 | - | | | Physical property: | Metal [MPa] | ≥ 12 | ≥ 12 | - | The subject device has the | | tensile | Porcelain [MPa] | ≥ 10 | ≥ 10 | - | same in-house specification | | bond strength 4) | Zirconia [MPa] | ≥ 10 | ≥ 10 | - | as the predicate device.. | | | Resin material including inorganic filler * [MPa] | ≥ 10 | ≥ 10 | | | | Sterilization | | Non-sterile | Non-sterile | Non-sterile | Identical | | Shelf life | | 2 years at a temperature between 0-25°C (32-77F°) | 3 years at a temperature between 0-10°C (32-50F°) | 2 years at a temperature between 0-25°C (32-77F°) | Similar The shelf life of the subject device is within that of the predicate and the reference devices. | {8}------------------------------------------------ 1) According to the brochure "A Collection of Scientific Facts - Scotchbond Universal Adhesive", Scotchbond Universal and Adhesive EXL 759 are the same product. 2) 510(k) number of Adhesive EXL 759 3) Materials of Scotchbond Universal Adhesive are described in the SDS. 4) In-house specification {9}------------------------------------------------ #### Non-clinical Testing Non-clinical testing of the following physical properties was conducted on the TOKUYAMA UNIVERSAL BOND II 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 purs…