[1] Direct restorations using light-cured composite resin
[2] Cavity sealing as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Treatment of hypersensitive teeth
[5] Intraoral repairs of fractured restorations
[6] Post cementation using a dual- or self-cured composite resin
[7] Core build-ups using a light-, dual- or self-cured core material
[8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement

Device Description

The subject device is a two component, self-etch, light-cured bonding agent, which is intended for universal use for both direct and indirect restorations. The PRIMER allows simultaneous treatment of both dentin and enamel using one liquid. The product is activated by a dual-cure mechanism when the BOND is mixed with CLEARFIL DC Activator. This allows it to be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.

AI/ML Overview

This document is a 510(k) summary for a dental bonding agent, CLEARFIL SE BOND 2. It's a regulatory submission to the FDA and therefore lacks the typical detailed study information you'd find in a peer-reviewed publication. Dental bonding agents are typically evaluated through benchtop tests rather than large-scale clinical studies with human readers, multi-reader multi-case studies, or complex ground truth requirements like pathology or outcomes data in the way medical imaging AI devices are.

However, I can extract the available information regarding acceptance criteria and the study performed, even if it's limited in scope compared to your requested format for AI/imaging devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document states there are no international standards for the performance of this type of device. Therefore, a comparative approach against predicate devices was used. The key performance metric mentioned is tensile bond strength.

Acceptance Criteria	Reported Device Performance
Tensile bond strength not significantly different or not less than that of predicate devices	Each tensile bond strength of the subject device was not significantly different or not less than that of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: Not explicitly stated. The document mentions "certain tests were performed on this device" but does not detail sample sizes for these tests.
Data Provenance: Not specified. Given it's a submission from a Japanese company (Kuraray Noritake Dental Inc.), the tests were likely conducted internally or by a contracted lab. The document does not specify if it's retrospective or prospective; however, these would be benchtop tests, not clinical studies in the typical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable. For tensile bond strength and other physical/chemical properties of dental materials, the "ground truth" is established through standardized laboratory testing protocols, not by expert consensus or interpretation in the way medical images are.
Qualifications of Experts: Not applicable in the context of expert review for ground truth. The tests would be performed by lab technicians or scientists following established ISO or internal protocols for material testing.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable. As ground truth is established through physical/chemical testing, there is no need for expert adjudication of results.

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

MRMC Study: No. This is a dental material, not an AI or imaging device that involves human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a dental material, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Physical/chemical properties determined through laboratory testing (specifically, tensile bond strength as mentioned). This is a direct measurement based on established test methodologies for material science, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set Establishment: Not applicable. There is no training set for this type of device.

Study Summary:

The study performed was a benchtop comparative effectiveness study where the tensile bond strength of the CLEARFIL SE BOND 2 was compared against its predicate devices. The study aimed to demonstrate that the subject device's performance was "not significantly different or not less than" that of the predicate devices in terms of tensile bond strength. This approach was taken because "there have not been any international standards concerning performance of this type of device." No specific details on the methodology, number of samples, or statistical analysis are provided in this summary. The safety evaluation was based on the chemical ingredients being equivalent to predicate devices with no reported post-market problems.

Summary

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[CLEARFIL SE BOND 2. Kuraray Noritake Dental Inc.] Section 3: Summary

Date: June. 12, 2013

510(k) Summary

K131432

3-1. 510(k) owner (submitter)

Name
Address
Contact person
Contact person in US

Kuraray Noritake Dental Inc.

1621 Sakazu. Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

CLEARFIL SE BOND 2

Dental bonding agent

Agent, Tooth Bonding, Resin

Goro Asanuma KURARAY AMERICA INC. 33 Maiden Lane, 6th Floor, New York, NY 10038 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543

(21 CFR section 872.3200. Product code: KLE)

AUG 2 2 2013

3-2. Name of Device

Trade / Proprietary name

1. Classification name

Common name

3-3. Predicate devices

1) CLEARFIL SE BOND	510(k) NumberClassification:Product Code:21 CFR Section:Applicant:	K012442Agent, Tooth Bonding, ResinKLE872.3200Kuraray Noritake Dental Inc.
2) CLERFIL DC BOND	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K062382Agent, Tooth Bonding, ResinKLE872.3200Kuraray Noritake Dental Inc.
3) Optibond XTR	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K101423Agent, Tooth Bonding, ResinKLE872.3200KERR CORPORATION
4) CLEARFIL TRI-S BOND PLUS	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K111980Agent, Tooth Bonding, ResinKLE872.3200Kuraray Noritake Dental Inc.
5) CLEARFIL DC CORE AUTOMIX	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K043177Material, Tooth Shade, ResinEBF872.3690Kuraray Noritake Dental Inc.

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3-4. Device Description

The subject device is a two component, self-etch, light-cured bonding agent, which is intended for universal use for both direct and indirect restorations. The PRIMER allows simultaneous treatment of both dentin and enamel using one liquid. The product is activated by a dual-cure mechanism when the BOND is mixed with CLEARFIL DC Activator. This allows it to be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.
This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.

3-5. Statement of Intended Use

The subject device is indicated for the following restorative applications:

[1] Direct restorations using light-cured composite resin
[2] Cavity sealing as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Treatment of hypersensitive teeth
[5] Intraoral repairs of fractured restorations
[6] Post cementation using a dual or self-cured composite resin
[7] Core build-ups using a light-, dual or self-cured core material
[8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement

3-6. Substantial Equivalence Discussion

l ) Intended uses
The intended uses of the subject device were written up based on those of the predicate devices. Therefore, the intended uses of the subject device are substantially equivalent to those of the predicate devices.

2) Chemical ingredients/ Safety

All ingredients in the subject have been used in the predicate devices.

Regarding the predicate devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US,

In conclusion, it can be said that the safety of the subject device is substantially equivalent to that of the predicate devices.

3) Technological characteristics/ Effectiveness and Performance

Since there have not been any international standards concerning performance of this type of device, certain tests were performed on this device considering its intended uses, in comparison with the predicate device.

As the result of the testing, it was confirmed that each tensile bond strength of the subject device was not significantly different or not less than that of the predicate devices.

Therefore, it was considered that the subject device was as effective as and performs as good as the predicate device.

In conclusion, it can be said that the effectiveness and performance of the subject device are substantially equivalent to those of the predicate device.

3-7. Biocompatibility

The subject device is categorized into the external communicating device (tissue/ bone/ dentin) and permanent contact device.

All the chemical ingredients of the subject device are equivalent to those of the predicate devices. Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.

Accordingly. it was considered that the subject device was substantially equivalent in safety to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping, curved shapes that resemble ribbons or stylized wings. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 22, 2013

Kuraray Noritake Dental, Inc. C/O Mr. Goro Asanuma General Manger. Dental Materials Division Kurarav America, Incorporated 33 Maiden Lane, 6th Floor New York, NY 10038

Re: K131432

Trade/Device Name: Clearfil SE Bond 2 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE, EMA, EBF Dated: June 12, 2013 Received: June 14, 2013

Dear Mr. Asanuma:

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.

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Page 2 - Mr. Asanuma

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Image /page/3/Picture/7 description: The image shows the name "Mary S. Runner -S" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. The name appears to be a signature or title, with the "S." possibly indicating a middle initial. The overall impression is clean and professional.

Kwame Ulmer M.S. Acting Division 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): _K131432

Device Name: CLEARFIL SE BOND 2

Indications for Use:

[1] Direct restorations using light-cured composite resin
[2] Cavity sealing as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Treatment of hypersensitive teeth
[5] Intraoral repairs of fractured restorations
[6] Post cementation using a dual- or self-cured composite resin
[7] Core build-ups using a light-, dual- or self-cured core material
[8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ N/A (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I-Steen-S
2013.08.20 14:10:21 -04'00'

(Division Sign-Off) (Division Sign-Off)
Division of Anestheslology, General Hospital
Division of Anestheslology, General Devices Division of Antost. Dental Devices

K131432 510(k) Number;

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.