Direct restorations using light-cured composite resin or compomer
Cavity sealing as a pretreatment for indirect restorations
Treatment of hypersensitive and/or exposed root surfaces
Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics or composite resin using light cured composite resin
Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
Core build-ups using light- or dual-cured composite resin
Cavity sealing under amalgam restorations

Device Description

CLEARFIL SE BOND PLUS is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. This device consists of the primer, the bond and the accessories, and is substantially equivalent in design to CLEARFIL SE BOND.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for a dental adhesive system called "CLEARFIL SE BOND PLUS". The submission aims to establish substantial equivalence to predicate devices, rather than proving the device meets specific acceptance criteria in a study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a diagnostic AI device is not available in this document.

However, I can extract information related to the device's properties and comparisons to predicate devices, which serve as a form of "acceptance criteria" in the context of a 510(k) submission for a non-AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on equivalence to predicate devices)	Reported Device Performance
Safety (Biocompatibility): Substantially equivalent safety to legally marketed predicate devices.	Biocompatibility of the new ingredient (MDPB) and the device as a whole were evaluated according to ISO 7405:1997 and ISO 10993-1:1997. The device was judged to be substantially equivalent in safety to the legally marketed predicate devices.
Effectiveness (Mechanical Properties - Bond Strengths): Bond strengths between bovine tooth and composite resin/fresh amalgam, and between composite resin and various substances for intra-oral repairs, substantially equivalent to legally marketed predicate devices.	The bond strengths between bovine tooth and a composite resin and a fresh amalgam were evaluated in comparison with legally marketed predicate devices (e.g., CLEARFIL SE BOND). Additionally, bond strengths between composite resin and various substances were evaluated for intraoral repairs of fractured crowns/bridges. The device was found to be substantially equivalent in effectiveness to the legally marketed predicate devices.
Effectiveness (Marginal Sealing): Marginal sealing for direct filling and cavity sealing under amalgam restoration substantially equivalent to legally marketed predicate devices.	Marginal sealing was evaluated when the device was used for direct filling and cavity sealing under amalgam restoration. The device was found to be substantially equivalent in effectiveness to the legally marketed predicate devices.
Physical Properties (Fluoride Releasing): Amount of fluorine ion released and changes in mechanical strength due to fluorine releasing, substantially equivalent to legally marketed predicate devices.	The amount of fluorine ion from the cured material immersed in water was evaluated in comparison with predicate devices (e.g., TOKUYAMA ONE-UP-BOND F, IMPERVA FLUORO BOND, PANAVIA F). Changes in mechanical strength due to fluorine releasing were also evaluated. The device was found to be substantially equivalent in the fluoride releasing property, including the change of mechanical strength, to the legally marketed predicate devices.

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

The document does not specify a "test set" in the context of an AI study. For the evaluated properties (biocompatibility, mechanical properties, physical properties), the specific sample sizes used for testing are not provided. The data provenance is described as being generated from various tests performed by Kuraray Medical Inc. and compared against their own and other manufacturers' predicate devices. The country of origin of the data would be Japan, where Kuraray Medical Inc. is based. The studies would be considered prospective for the "CLEARFIL SE BOND PLUS" device, as they were conducted to support its 510(k) submission.

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

This information is not applicable. The document describes laboratory-based testing of material properties, not an evaluation requiring expert consensus on a test set to establish ground truth in an AI/diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable. There was no adjudication method described as it pertains to expert reviews of a test set, which is common in AI studies.

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

No. This is a submission for a dental adhesive system, not an AI or diagnostic device that would involve human readers or MRMC studies.

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

No. This document does not describe an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established scientific standards and methods for evaluating biomaterial properties (e.g., ISO standards for biocompatibility), and comparative performance against legally marketed predicate devices. For bond strength and physical properties, the "ground truth" is derived from quantitative measurements obtained through standardized laboratory tests.

8. The Sample Size for the Training Set

This information is not applicable, as this is not an AI/machine learning device. The term "training set" is not relevant here.

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

This information is not applicable, as this is not an AI/machine learning device.

Summary

{0}------------------------------------------------

K023842

Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" design. The word "KURARAY" is printed in a bold, sans-serif font below the symbol.

KURARAY MEDICAL INC.

Dental Material Department 3-1-6 Nihonbashi, Chuo-ku, Tokyo 103-8254, Japan Tel : +81.3.3277.6949 Fax : +81.3.3277.6956

510(k) SUMMARY

Submitter
1) Name	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-8622, Japan
3) Contact person	Koji Nishida
	Dental Material Department
4) Date	November 11, 2002
5) Contact person in U.S.A.	Masaya Sasaki
	Kuraray America, Inc.
	101 East 52nd Street, 26th Floor, New York, NY 10022
	Telephone: (212)-986-2230 (Ext.115)
	Facsimile: (212)-867-3543

: !. Name of Device

1) Proprietary Name	CLEARFIL SE BOND PLUS
2) Classification Name	Resin tooth bonding agent (21CFR 872.3200)
3) Common/Usual Name	Resin-based dental adhesive system

:). Predicate device:
The predicate products are;
a) Resin Tooth Bonding Agent

1.	CLEARFIL SE BOND	by Kuraray Medical Inc.	(K012442)
2.	CLEARFIL LINER BOND 2V	by Kuraray Medical Inc.	(K012440)
3.	TOKUYAMA ONE-UP-BOND F	by Tokuyama America Inc.	(K993917)
4.	IMPERVA FLUORO BOND	by Shofu Dental Corp.	(K953612)
5.	PRIME & BOND NT DUAL CUREUNIVERSAL DENTAL ADHESIVE SYSTEM	by Dentsply Intl.	(K982394)
6.	OPTIBOND SOLO PLUS 4	by KERR DENTALMATERIALS CENTER.	(K014027)
b)	Other dental materials
1.	PANAVIA F	by Kuraray Medical Inc.	(K012441)
2.	SEAL & PROTECT PROTECTIVE SEALANT	by Dentsply Intl.	(K021805)
3.	PANAVIA EX	by Kuraray Co., Ltd.	(K855211)

1. ESTENIA
  (K012707) by Kuraray Medical Inc.
1. Description for the premarket notification
  CLEARFIL SE BOND PLUS is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.

{1}------------------------------------------------

5 Staterient of the intended use

This device has the following indications for use which are substantially equivalent to the legally marketed predicate devices.

Indications for use	Predicate device
1) Direct restorations using light-cured composite resin orcompomer	CLEARFIL SE BOND(K012442)
2) Cavity sealing as a pretreatment for indirect restorations
3) Treatment of hypersensitive and/or exposed root surfaces
4) Intraoral repairs of fractured crowns/bridges made ofporcelain, hybrid ceramics or composite resin usinglight-cured composite resin
5) Surface treatment of prosthetic appliances made ofporcelain, hybrid ceramics and cured composite resin
6) Core build-ups using light- or dual-cured composite resin	OPTIBOND SOLO PLUS 4(K014027)
7) Cavity sealing under amalgam restorations	PRIME & BOND NT DUALCURE UNIVERSAL DENTALADHESIVE SYSTEM(K982394)

3. Statement of the technological characteristics and safety

3-1 Design/Components

This device consists of the primer, the bond and the accessories, and is substantially equivalent in design to CLEARFIL SE BOND.

6-2 Material and chemical ingredients

The ingredients other than MDPB are used in the legally marketed predicate devices, C. EARFIL SE BOND etc. The biocompatibilities of the new ingredient, MDPB, and this device were evaluated according to ISO 7405: 1997 and ISO 10993-1: 1997. As to the results, this device is judged that it is substantially equivalent in safety to the legally marketed predicate devices.

6-3 Mechanical properties

The bond strengths between bovine tooth and a composite resin and a fresh amalgam were evaluated in comparison with the legally marketed predicate devices; CLEARFIL SE BOND etc. The bond strengths between composite resin and various substances were evaluated when used as intra oral repairs of fractured crowns/bridges. The marginal sealing was also evaluated when used as direct filling and cavity sealing under amalgam restoration. As to the result, this device is substantially equivalent to the legally marketed predicate devices in effectiveness.

6-4 Physical properties

The amount of fluorine ion from the cured material immersed in water was evaluated in comparison with the legally marketed predicate devices; TOKUYAMA ONE UP-BOND F IMPERVA FLUORO BOND and PANAVIA F. The changes in mechanical strength due to fluorine releasing were also evaluated. As to the result, this device is substantially equivalent in the fluoride releasing property including the change of mechanical strength to the legally

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its head and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter of the circle.

FEB 11 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical, Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022

Re: K023842

Trade/Device Name: CLEARFIL SE BOND PLUS Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 12, 2002 Received: November 18, 2002

Dear Ms. Sasaki:

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.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{3}------------------------------------------------

Page 2 - Ms. Sasaki

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Penner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

[CLEARFIL SE BOND PLUS, Kuraray Medical Inc.]

3842 162

Indications for Use

('LEAFIL SE BOND PLUS is indicated for the following applications'

1. :Direct restorations using light-cured composite resin or compomer
1. Cavity sealing as a pretreatment for indirect restorations
1. 'Treatment of hypersensitive and/or exposed root surfaces
1. Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics or composite resin using light cured composite resin
1. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
1. Core build-ups using light- or dual-cured composite resin
1. Cavity sealing under amalgam restorations

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part: 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Kein Mulay for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

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.