The subject device activates the dual-curing mechanism of the CLEARFIL BONDING SYSTEM (c.g. CLEARFIL SE BOND 2 or CLEARFIL SE Protect). The product is mixed with the BOND and can be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.

AI/ML Overview

This document describes the CLEARFIL DC Activator, a dental product designed to activate the dual-curing mechanism of the CLEARFIL BONDING SYSTEM. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study Type
Tensile Bond Strength to Bovine Enamel: Not significantly different or not less than the predicate device.	"each tensile bond strength of the subject device to bovine enamel...was not significantly different or not less than that of the predicate device."	Comparison study against predicate device
Tensile Bond Strength to Bovine Dentin: Not significantly different or not less than the predicate device.	"each tensile bond strength of the subject device to bovine dentin was not significantly different or not less than that of the predicate device."	Comparison study against predicate device

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

The document does not explicitly state the specific sample sizes used for the tensile bond strength tests on bovine enamel and dentin. However, it indicates that comparisons were made to a predicate device.

The provenance of the data is not specifically mentioned regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a dental product, it is most likely laboratory-based testing conducted by the manufacturer, which would be prospective in nature.

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

Not applicable. This device is a chemical activator for a bonding system, and its performance is evaluated based on objective physical properties (tensile bond strength), not subjective interpretation by experts. Ground truth in this context is established by the results of the physical tests themselves.

4. Adjudication Method for the Test Set

Not applicable. The evaluation relies on quantitative measurements (tensile bond strength), not on expert consensus or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human readers assess outputs (e.g., medical imaging). This device is a chemical product, and its performance is assessed through physical property testing.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance assessment was done. The "device" in this context is the CLEARFIL DC Activator itself, and its performance (tensile bond strength) was measured directly. There is no "human-in-the-loop" aspect to its function or evaluation, as it is a chemical component.

7. Type of Ground Truth Used

The ground truth used was objective physical measurements (tensile bond strength) obtained from laboratory testing. The comparison was made against the performance of a predicate device, establishing statistical equivalence or non-inferiority.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set." The performance is determined through experimental testing, not through model training.

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

Not applicable, as there is no training set for this device.

Summary

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[CLEARFIL DC Activator, Kuraray Noritake Dental Inc.] Section 3: Summary

Date: June. 12, 2013

KIJI 430

510(k) Summary

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

I) Name

Address
Contact person
Contact person in US

Kuraray Noritake Dental Inc.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

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

AUG 3 0 2013

3-2. Name of Device

Trade / Proprietary name
Classification name

CLEARFIL DC Activator

Agent Tooth Bonding, Resin (21 CFR section 872.3200. Product code: KLE)

Dental bonding agent

510(k) Number:

Classification:

Product Code:

21 CFR Section:

Applicant:

3-3. Predicate device

Common name
Self-Cure Activator

Applicant: 510(k) Number: 2) CLEARFIL NEW BOND Classification: Product Code:

K050386 Agent, Tooth Bonding, Resin KLE 872.3200 DENTSPLY INTERNATIONAL INC.

K012734 Agent, Tooth Bonding, Resin KLE 872.3200 Kuraray Noritake Dental Inc.

3-4. Device Description

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

When used with the CLEARFIL BONDING SYSTEM, the product is indicated for the following uses.

[1] Core build-up in conjunction with self- or dual- cured core build-up materials

[2] Cementation in conjunction with self- or dual- cured composite resin cements

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3-6. Substantial Equivalence Discussion

l) Intended uses
The intended use of the subject device was written up based on that of the predicate device. Therefore, the intended use of the subject device is substantially equivalent to that of the predicate device.
1. Chemical ingredients/ Safety
  All ingredients in the subject device have been used in the predicate device. Regarding the predicate device, 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 device.
1. 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 use, in comparison with the predicate device.

As the result of testings. it was confirmed that each tensile bond strength of the subject device to bovine cnamel or bovine dentin was not significantly different or not less than that of the predicate device. 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 device.

Regarding the predicate device, 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

August 30, 2013

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

Re: K131430

Trade/Device Name: Clearfil DC Activator Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE 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), i 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 (OS) 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Kwame Ulmer

Lester W. Schultheis Jr

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): ___ K131430

Device Name: CLEARFIL DC Activator

Indications for Use:

When used with the CLEARFIL BONDING SYSTEM, the product is indicated for the following uses.

[1] Core build-up in conjunction with self- or dual- cured core build-up materials

[2] Cementation in conjunction with self- or dual- cured composite resin cements

Prescription Use _ V (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) Lauren M. Giles for AIS 2013.08.30 10:40:26 -04'00'

(Division Sign-Off) (Division Olgh Oly). General Hospital Infection Control, Dental Devices

510(k) Number: K131430

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.