[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 and core build-ups
[7] Cementation of inlays, onlays, crowns, bridges and veneers

Device Description

The subject device is a single-component, light-cured bonding agent that allows simultaneous treatment of both dentin and enamel. Depending on the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures. This product is intended to be used for both direct and indirect restorations.

"CLEARFIL DC Activator" activates the dual-curing mechanism of this product; however, the addition of "CLEARFIL DC Activator" to the adhesive is not required when using with "CLEARFIL DC CORE PLUS" or "PANAVIA SA CEMENT"

This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.

AI/ML Overview

The provided text is for a dental bonding agent (CLEARFIL Universal Bond, Kuraray Noritake Dental Inc.). This type of device does not typically involve AI, image analysis, or diagnostic capabilities that would require the detailed acceptance criteria and study designs you've requested regarding AI performance.

Therefore, many of the requested points are not applicable to this submission. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, chemical ingredients/safety, and technological characteristics/performance through in vitro tests, not clinical studies with human readers or AI.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific quantitative acceptance criteria or performance metrics for in vitro tests. Instead, it states a qualitative conclusion regarding performance compared to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Performance not significantly different or not less than predicate devices	"the performance of the subject device was not significantly different or not less than that of the predicate devices."
Substantially equivalent in safety to predicate devices (chemical ingredients, no reported problems/recalls for predicates)	"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... it was concluded that the safety of the subject device was substantially equivalent..."

2. Sample size used for the test set and the data provenance

Not Applicable: This device is not an AI diagnostic tool and does not use a "test set" in the context of AI model evaluation. The tests performed were likely in vitro (laboratory tests) to assess bonding strength, durability, etc., but no details on sample size or data provenance (country of origin, retrospective/prospective) are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: Ground truth as described (e.g., established by radiologists) is not relevant for this type of dental material.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable: No adjudication method is described, as it's not a diagnostic device.

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 not an AI-assisted diagnostic device, so no MRMC study or AI-human improvement metrics are relevant.

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

Not Applicable: This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)

Not Applicable/Implied by comparison: For dental materials, "ground truth" often refers to scientifically validated physical, chemical, or biological properties obtained through standardized laboratory testing. The document states "certain tests were performed on this device considering its intended uses, in comparison with the predicate device," implying the ground for comparison came from standard material testing protocols.

8. The sample size for the training set

Not Applicable: This is not an AI device, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable: As above, no training set.

Summary

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K132450 [CLEARFIL Universal Bond, Kuraray Noritake Dental Inc.] Section 3: Summary

September 3, 2013 Date:

510(k) Summary

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

l ) Name

Address

NOV 0 1 2013

Contact person
Contact person in US

Kuraray Noritake Dental Inc.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

CLEARFIL Universal Bond

Agent, Tooth Bonding, Resin

Dental bonding agent

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)

3-2. Name of Device

Trade / Proprietary name

1. Classification name

Common name

3-3. Predicate devices

a a s a le while de contract and the count
1) CLEARFIL TRI-S BOND PLUS	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K111980Agent, Tooth Bonding, ResinKLE872.3200Kuraray Noritake Dental Inc.
2) Scotchbond Universal Adhesive	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	UnknownAgent, Tooth Bonding, ResinKLE872.32003M ESPE
3) CLEARFIL TRI-S BOND	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K042913Agent, Tooth Bonding, ResinKLE872.3200Kuraray Noritake Dental Inc.
4) CLEARFIL CERAMIC PRIMER	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K061906Material, Tooth shade, ResinEBF872.3690Kuraray Noritake Dental Inc.

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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

The subject device is indicated for the following uses:

[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 and core build-ups

[7] Cementation of inlays, onlays, crowns, bridges and veneers

3-6. Substantial Equivalence Discussion

l ) Intended uses
The intended uses of the subject device were written up based on those of CLEARFIL TRI-S BOND PLUS and Scotchbond Universal Adhesive.

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.

Accordingly, it was concluded that the safety of the subject device was substantially equivalent to that of the predicate devices.

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 testings, it was confirmed that the performance 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.

Accordingly, it was concluded that the effectiveness and performance of the subject device were substantially equivalent to those of the predicate devices.

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 concluded that the subject device was substantially equivalent in safety to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

November 1, 2013

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

Re: K132450

Trade/Device Name: Clearfil Universal Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE, LBH Dated: September 3, 2013 Received: September 6, 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 (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,

Mary Si Runner -S

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): K132450

Device Name: CLEARFIL Universal Bond

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 and core build-ups
[7] Cementation of inlays, onlays, crowns, bridges and veneers

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)

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9.2342.19200300.100.1.1=2000646

for AIS

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.