(153 days)
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
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.
The provided document describes the TOKUYAMA UNIVERSAL BOND II, a dental adhesive. The acceptance criteria and the study to prove the device meets these criteria are outlined through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (In-house specification derived from predicate device) | Reported Device Performance (TOKUYAMA UNIVERSAL BOND II) |
|---|---|
| Enamel: ≥ 12 MPa | Performance met or exceeded this value (implied by "Similar" in comparison table and "concluded that the TOKUYAMA UNIVERSAL BOND II device is substantially equivalent to the primary predicate device"). Specific values are not provided in the summary. |
| Dentin: ≥ 10 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Metal: ≥ 12 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Porcelain: ≥ 10 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Zirconia: ≥ 10 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Resin material including inorganic filler: ≥ 10 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Working time: Not cured after three minutes | Device was confirmed not cured after three minutes. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes (number of replicates or specimens) used for each tensile bond strength test. However, it indicates that testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. This ISO standard typically specifies details on sample preparation and testing procedures.
The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Tokuyama Dental Corporation, located in Tokyo, Japan. The testing is non-clinical bench testing, so it is retrospective in the sense that it evaluates the manufactured device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a non-clinical bench testing study for a dental adhesive, not a study involving diagnostic interpretation or human expert judgment to establish ground truth for a test set. The ground truth for performance is objective physical measurements based on established ISO standards.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is non-clinical bench testing with objective physical measurements. There is no subjective adjudication required.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a non-clinical study for a dental adhesive, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-clinical study for a dental adhesive, not an algorithm. The device's performance is measured standalone from human intervention other than its application as per the instructions for use.
7. The Type of Ground Truth Used:
The ground truth used for performance evaluation is objective physical measurements of tensile bond strength and working time, compared against pre-defined in-house specifications (derived from the predicate device) and ISO standards. Biocompatibility was also assessed in accordance with ISO 10993-1:2009.
8. The Sample Size for the Training Set:
Not applicable. This device is a dental adhesive, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.
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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
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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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 |
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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.
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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
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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.
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Comparison of TOKUYAMA UNIVERSAL BOND II device with the primary predicate and reference devices
| Subject device | Primary predicate | Reference | Difference | ||
|---|---|---|---|---|---|
| Device name | TOKUYAMA UNIVERSALBOND II | TOKUYAMA UNIVERSALBOND | 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 posteriorrestorations with light-curing,dual-curing, and self-curingcomposite materials-Intraoral repair of compositerestorations, porcelain fused tometal, metal, and all-ceramicrestorations without anadditional primer-Cementation of indirectrestorations and veneers whencombined with light-cure, dual-cure, and self-curing resincements-Bonding of core build-upsmade of core build-upmaterials-Bonding of denture resin tometal base, clasp or attachment-Repair of denture with metalbase, clasp or attachment-Bonding of opaque resin to ametal base in the fabrication ofresin-faced crowns | The TOKUYAMA UNIVERSALBOND is indicated for:-Direct anterior and posteriorrestorations with light-curing,dual-curing, and self-curingcomposite materials-Intraoral repair of compositerestorations, porcelain fused tometal, metal, and all-ceramicrestorations without an additionalprimer-Cementation of indirectrestorations and veneers whencombined with light-cure, dual-cure, and self-curing resincements-Bonding of core build-ups madeof core build-up materials-Bonding of denture resin to metalbase, clasp or attachment-Repair of denture with metal base,clasp or attachment-Bonding of opaque resin to ametal base in the fabrication ofresin-faced crowns | -All classes of fillings(according to Black) with light-curing composite or compomerfilling materials-Cementation of indirectrestorations when combinedwith RelyX Ultimate AdhesiveResin Cement-Cementation of veneers whencombined with RelyX VeneerCement-Bonding of core build-upsmade of light-curing compositeor core build-up materials-Bonding of dual-cure cementsand core build-up materials andself-cure composites whencombined with ScotchbondUniversal DCA-Repair of composite orcompomer fillings-Intraoral repair of compositerestorations, porcelain fused tometal, and all-ceramicrestorations without extraprimer-Root surface desensitization-Sealing of cavities prior tocementation of amalgamrestorations-Sealing of cavities andpreparation of tooth stumpsprior to temporarycementation of indirectrestorations-Bonding of fissure sealants-Protective varnish for glassionomer fillings | SimilarThe Indications for Use ofsubject device is within that ofthe predicate and the referencedevices. | |
| Component | Consisting of Bond A andBond B in separate bottles | Consisting of Bond A and Bond Bin separate bottles | Bottle or unit-dose | SimilarThe subject device uses abottle that is slightly differentfrom the one used for thepredicate device. | |
| Principle of operation | The device functions as anadhesive layer for enhancing anadhesiveness of polymerizableresin to adherends, and is usedby applying on the surface ofadherends. | The device functions as anadhesive layer for enhancing anadhesiveness of polymerizableresin to adherends, and is used byapplying on the surface ofadherends. | The device functions as anadhesive layer for enhancing anadhesiveness of polymerizableresin to adherends, and is usedby applying on the surface ofadherends. | Similar | |
| Material 3) | - Phosphoric acid monomer- Bisphenol A di(2-hydroxypropoxy) dimethacrylate (Bis-GMA)- Triethylene glycoldimethacrylate (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-hydroxypropoxy) dimethacrylate (Bis-GMA)- Triethylene glycoldimethacrylate (TEGDMA)- 2-Hydroxyethyl methacrylate(HEMA)- MTU-6 (thiouracil monomer)- Silane coupling agent- Peroxide- Borate catalyst- Acetone- Isopropnanol- Water | -2-HYDROXYETHYLMETHACRYLATE- BISPHENOL ADIGLYCIDYL ETHERDIMETHACRYLATE (BIS-GMA)-2-PROPENOIC ACID, 2-METHYL-, REACTIONPRODUCTS WITH 1,10-DECANEDIOL ANDPHOSPHOROUS OXIDE(Phosphoric acid monomer)- ETHANOL-2-PROPENOIC ACID, 2-METHYL-, 3-(TRIMETHOXYSILYL)PROPYL ESTER, REACTIONPRODUCTS WITHVITREOUS SILICA-COPOLYMER OFACRYLIC AND ITACONICACID-CAMPHORQUINONE- DIMETHYLAMINOBENZOAT(-4)-(DIMETHYLAMINO)ETHYL METHACRYLATE | SimilarThe subject device contains aphosphate monomer,methacrylic monomer,adhesive compound toprosthetic materials, initiator,catalyst and solvent as with thepredicate device. | |
| Enamel [MPa] | ≥ 12 | ≥ 12 | - | Similar | |
| Dentin [MPa] | ≥ 10 | ≥ 10 | - | ||
| Physicalproperty: | Metal [MPa] | ≥ 12 | ≥ 12 | - | The subject device has the |
| tensile | Porcelain [MPa] | ≥ 10 | ≥ 10 | - | same in-house specification |
| bondstrength 4) | Zirconia [MPa] | ≥ 10 | ≥ 10 | - | as the predicate device.. |
| Resin materialincludinginorganic filler *[MPa] | ≥ 10 | ≥ 10 | |||
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Identical | |
| Shelf life | 2 years at a temperaturebetween0-25°C (32-77F°) | 3 years at a temperature between0-10°C (32-50F°) | 2 years at a temperaturebetween0-25°C (32-77F°) | SimilarThe shelf life of the subjectdevice is within that of thepredicate and the referencedevices. |
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-
According to the brochure "A Collection of Scientific Facts - Scotchbond Universal Adhesive", Scotchbond Universal and Adhesive EXL 759 are the same product.
-
510(k) number of Adhesive EXL 759
-
Materials of Scotchbond Universal Adhesive are described in the SDS.
-
In-house specification
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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 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 three minutes.
The precise formulation of the device is confidential. Substantial biocompatibility testing was evaluated in accordance with ISO 10993-1:2009.
The device was also designed following principles of ISO 14971 Second Edition 2007-03-01 Medical Devices - Application of Risk Management to Medical Devices
Clinical Testing
There were no clinical tests performed for the TOKUYAMA UNIVERSAL BOND II device.
Conclusions from Testing
Based on the non-clinical testing conducted of the physical properties and the biocompatibility testing of the TOKUYAMA UNIVERSAL BOND II device, it is concluded that the TOKUYAMA UNIVERSAL BOND II device is substantially equivalent to the primary predicate device identified above.
§ 872.3200 Resin tooth bonding agent.
(a)
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.(b)
Classification. Class II.