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

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental adhesive device, the TOKUYAMA UNIVERSAL BOND. It describes the device, its intended use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does NOT describe an AI/ML-based medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design for AI models (sample size, data provenance, ground truth, expert adjudication, MRMC studies, standalone performance, training set details).

The Acceptance Criteria and Study Proof for the TOKUYAMA UNIVERSAL BOND device are entirely based on physical property testing as it is a material-based dental product, not an AI diagnostic or assistance tool.

Here's a summary of the acceptance criteria and proof as presented for this specific dental device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TOKUYAMA UNIVERSAL BOND device are based on achieving certain tensile bond strengths to various dental materials, as well as satisfactory working time, paintability, and appearance.

Acceptance Criteria Item	Acceptance Criteria (In-house Specification)	Reported Device Performance (TOKUYAMA UNIVERSAL BOND)
Tensile bond strength to enamel	> 12 MPa	> 12 MPa
Tensile bond strength to dentin	> 10 MPa	> 10 MPa
Tensile bond strength to metal	> 12 MPa	> 12 MPa
Tensile bond strength to porcelain	≥ 10 MPa	≥ 10 MPa
Tensile bond strength to zirconia	≥ 10 MPa	≥ 10 MPa
Tensile bond strength to resin material including inorganic filler	≥ 10 MPa	≥ 10 MPa
Working time	Cured after 90 seconds (Confirmation)	Confirmed to be cured after 90 seconds
Paintability	Even film formed (Evaluation)	Even film formed
Appearance	Visual inspection (Normal)	Normal

(Note: The tables in the original document present the performance of the predicate and reference devices against the same specifications, with all devices meeting these criteria.)

Study that Proves the Device Meets the Acceptance Criteria:

The study conducted is a series of non-clinical, benchtop physical property tests.

Sample size used for the test set and data provenance:
- The document does not explicitly state the sample size (number of individual samples or replicates tested) for each physical property. It only states that "Non-clinical testing of the following physical properties was conducted."
- Data Provenance: The tests were conducted by Tokuyama Dental Corporation, based in Japan. This implies the data originates from their internal laboratory testing. The data is retrospective in the sense that it was generated prior to the 510(k) submission.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. For physical property testing of a dental material, "ground truth" is established by the direct measurement of physical properties (e.g., bond strength in MPa) using established testing standards (ISO/TS 11405:2015). This does not involve human expert adjudication or consensus in the way an AI diagnostic would require for image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As this is a physical property test, not an interpretive one, there is no adjudication process involving multiple human readers. The measurement results are directly compared against the pre-defined in-house specifications.
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 device is a material, not an AI or a system that assists human readers. Therefore, an MRMC study is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device has no algorithm and does not perform any diagnostic or interpretive function. Its performance is intrinsic to its physical and chemical properties.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is the direct, quantitative measurement of physical properties (tensile bond strength) and qualitative assessments (working time, paintability, appearance) against pre-defined, standardized specifications. The testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015 for tensile bond strength tests.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.

In summary, the provided document pertains to a dental bonding agent, and therefore the "acceptance criteria" and "proof" relate to its physical and chemical characteristics and performance as a material, rather than the statistical or clinical performance metrics associated with AI/ML medical devices.

Summary

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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);

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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

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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)

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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

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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 device is depicted below:

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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

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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.

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226
IL
I
K#

Device name	Manufacturer510(k) No.Classificationname	Subject deviceTOKUYAMA UNIVERSALBONDTokuyama Dental CorporationK171226Agent, Tooth Bonding, Resin	Primary predicateAdhesive EXL 7593M ESPE AGK110302Agent, Tooth Bonding, Resin	ReferenceFuturabond UniversalVOCO GmbHK130486Agent, Tooth Bonding, Resin	ReferenceAlloy PrimerKuraray Noritake Dental Inc.K012436Agent, Tooth Bonding, Resin	ReferenceEstecemTokuyama Dental CorporationK150727Cement, Dental	Difference
Indications for Use	The TOKUYAMA UNIVERSALBOND is indicated for:Direct anterior and posteriorrestorations with light-curing,dual-curing, and self-curingcomposite materialsIntraoral repair of compositerestorations, porcelain fused tometal, metal, and all-ceramicrestorations without anadditional primerCementation of indirectrestorations and veneers whencombined with light-cure, dual-cure, and self-curing resincementsBonding of core build-ups madeof core build-up materialsBonding of denture resin tometal base, clasp or attachmentRepair of denture with metalbase, clasp or attachmentBonding of opaque resin to ametal base in the fabrication ofresin-faced crowns	All classes of fillings (accordingto Black) with light-curingcomposite or compomer fillingmaterialsCementation of indirectrestorations (inlays, onlays,crowns, bridges, veneers) ofcomposite, compomer, cramic,and metal when combined withSuglue-10 Adhesive ResinCement, manufactured by 3MESPECementation of veneers whencombined with RelyX VeneerCement, manufactured by 3MESPEBonding of core build-ups madeof light-curing composite or corebuild-up materialsBonding of dual-cure cementsand core build-up materials andself-cure composites whencombined with Activator EXL760Repair of composite orcompomer fillingsIntraoral repair of compositerestorations, porcelain fused tometal, and all-ceramicrestorations without extraprimerRoot surface desensitization	Futurabond Universal isintended for use as:Adhesive for direct restorationsof all classes of cavities usinglight-curing composite/compomer/Ormocer materialswith a methacrylate baseAdhesive for core build-upsmade of light-curing compositematerialsAdhesive for indirectrestorations with light-curingluting compositesIntraoral repair of composite,compomer or Ormocerrstorations, ceramic veneersand all ceramic restorationswithout an additional primerTreatment of hypersensitivetooth necksProtective varnish for glassionomer cement restorationsSealing of cavities prior toamalgam restorationsSealing of cavities and corepreparations prior to thetemporary luting of indirectrestorationsAdhesive for direct self-curingor dual-curing compositerestorations of all classes of	ALLOY PRIMER is indicatedfor the following applications:1) Adhesion of metal posts,metal inlays, onlays, crownand bridges2) Repair of fractures resin-based facing crowns andporcelain-fused metalcrowns3) Fabrication of removabledentures with metal base,clasp or attachment. Repairof dentures	The ESTECEM device is anadhesive resin cement for thecementation of crowns, bridges,inlays, and onlays made ofglass/oxide ceramics (porcelain,zirconia and alumina),metals/alloys (precious andnon-precious) and resinmaterials including inorganicfiller (composite materials).The ESTECEM device isindicated for:Repair of fractured porcelainfused to metal crowns and allceramic restorationsCementation of veneersCementation of adhesionbridgesCementation of metal or resincores, metal or glass-fiber posts	The Indicationsfor Use of thesubject device iswithin that of thepredicate and thereference devices.

Comparison of TOKUYAMA UNIVERSAL BOND device with the primary predicate and the reference devices

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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
Manufacturer10(k) No.Material	Phosphate monomerBis-GMATEGDMAHEMAThiouracil monomer(functioning as adhesion to metal)Silane coupling agentPeroxideBorate catalyst (initiator)AcetoneIsopropanolWater	Phosphate monomerMethacrylate-modifiedpolyalkenoic acid copolymerDimethacrylate resinsHEMASilaneInitiatorsEthanolWater	Acidic monomersMethacrylatesCatalystsInitiatorsEthanolWater	Phosphate monomerVBATDT (functioning as adhesion to metal)Acetone	(Adhesive components such as Estelink and Tokuyama Universal Primer:)K150727Phosphate monomerCarboxylic acid monomerBis-GMATEGDMAHEMAUDMAThiouracil monomer(functioning as adhesion to metal)Silane coupling agentPeroxideBorate catalyst (initiator)AcetoneIsopropanolEthanolWater	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 ***	1I	-I
Leference	uturabond Universa	L LII	1I
Primary predicat0	759Adhesive EXL	ڪ اI	1I
Subject device	TOKUYAMA UNIVERSABOND	> 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 *

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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

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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.

Regulation Number and Section

§ 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.