Direct filling restorations using light-curing composite or compomer
Cavity sealing as a pretreatment for indirect restorations
Treatment of hypersensitive and/or exposed root surfaces
Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics and cured composite resin
Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

Device Description

CLEARFIL SE BOND 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 retentive materials.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for CLEARFIL SE BOND, based on the information available in the 510(k) summary.

It's important to note that the provided document is a 510(k) summary, which is a premarket notification to the FDA. These summaries typically demonstrate substantial equivalence to previously cleared devices rather than presenting full clinical trial results with detailed acceptance criteria and standalone performance studies in the way a pharmaceutical drug or a high-risk medical device might. Therefore, some of the requested information (like specific effect sizes for MRMC studies, sample sizes for test sets, and detailed expert qualifications) is not explicitly present in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Performance: Bond strengths to human enamel, human dentine, precious metal, and porcelain are substantially equivalent to predicate device CLEARFIL LINER BOND 2V (K974486).	The document states: "The bond strengths to human enamel, human dentine, precious metal, and porcelain were evaluated in comparison with predicate devices. The performances are substantially equivalent to those of CLEARFIL LINER BOND 2V." While specific numerical values for acceptance thresholds are not provided, the reported performance is that the device met the implicit criterion of "substantial equivalence" in bond strength to the predicate device.
Chemical Ingredients and Safety: Chemical ingredients are identical or substantially equivalent to predicate devices and have a history of safe use.	The document states: "The chemical ingredients are identical or substantially equivalent to the predicated devices. These chemical ingredients have been used in similar products which have been marketed for many years, therefore they are safe." The safety of the chemical ingredients is affirmed by their historical use in equivalent predicate devices (CLEARFIL LINER BOND 2V (K974486), PANAVIA F (K983361), ESTENIA (K982164)).
Design, Composition, and Function: Device is similar and substantially equivalent in design, composition, and function to predicate devices.	The document explicitly states: "This product is similar and substantially equivalent in design, composition and function to the similar products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial." This is a general statement of equivalence rather than a specific performance metric. The device is also described as a "simplified system of CLEARFIL LINER BOND 2V".
Intended Use: Device performs as intended for specified indications.	The Indications For Use are listed and the claim is that the device is "substantially equivalent" for these uses to predicate devices. Implicitly, it is deemed to perform for: 1) Direct filling restorations, 2) Cavity sealing, 3) Treatment of hypersensitive/exposed root surfaces, 4) Intraoral repairs of fractured crowns, and 5) Surface treatment of prosthetic appliances. The "substantially equivalent" claim implies that it performs comparably to the predicate devices for these indications.

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

The 510(k) summary does not specify the sample size used for the bond strength evaluations (test set). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature) for these evaluations. These details are typically part of a more extensive study report, not a 510(k) summary.

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

This information is not provided in the 510(k) summary. Bond strength testing is usually a laboratory-based biomechanical evaluation, not typically reliant on "expert ground truth" in the way image interpretation or diagnostic accuracy studies might be. Therefore, experts in establishing ground truth in that context would not be applicable here. The "ground truth" would be the measured bond strength values themselves.

4. Adjudication Method for the Test Set

Not applicable for this type of biomechanical bond strength evaluation. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or diagnostic results, not for objective laboratory measurements like bond strength.

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

This is not applicable. The device is a "Resin-based dental adhesive system," a physical material used in dentistry, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this device.

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

This is not applicable. As stated, the device is a dental adhesive system, not an algorithm. The "standalone performance" in this context would be the measured bond strength of the product itself under controlled laboratory conditions, which the document indicates was evaluated by comparing it to predicate devices.

7. The Type of Ground Truth Used

For the bond strength evaluations, the "ground truth" would be the measured bond strength values themselves, obtained through standardized laboratory testing methods (e.g., universal testing machine pulling apart bonded substrates). This is a direct physical measurement.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (dental adhesive), not a machine learning model that requires a training set.

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

This is not applicable, as there is no "training set" for this type of device.

Summary

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FEB 400000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 ধ

K990040

(K943170)

(K943165)

KURAF

12-39, 1-Chome, Umeda, Kita-ku, Osaka 530-86 : +81-6-6348-2603 Phone Facsimile: +81-6-6348-2552

510(k) SUMMARY

1. Submitter

1) Name	KURARAY CO., LTD.
2) Address	1-12-39, Umeda, Kita-ku, Osaka 530-8611, Japan
3) Telephone	81(Japan)-6-6348-2603
4) Facsimile	81(Japan)-6-6348-2552
5) Contact person	Yoshinori NagaseDental Material DepartmentMedical Products Division
6) Date	January 6, 1999

2. Representing (Subsidiary of KURARAY CO., LTD.)

1) Name	KURARAY AMERICA INC.
2) Address	30th Fl. Metlife Building, 200 Park Avenue, New York,NY 10166
3) Telephone	(212)-986-2230
4) Facsimile	(212)-867-3543
5) Contact person	Koji FujitaPresident

3. Name of Device

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

র্ব-Predicate devices:

	1. CLEARFIL LINER BOND 2V by KURARAY CO.,LTD.	(K974486)
--	-----------------------------------------------	-----------

CLEARFIL LINER BOND 2 by KURARAY CO.,LTD. 2.
1. CLEARFIL PHOTO BOND by KURARAY CO.,LTD.
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) 4. BONDING AGENT WITH ACTIVATOR by DENTSPLY
GLUMA ONE BOND by HERAEUS KULZER, INC. (K974390) 5. (K#unknown) ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM by BISCO, 6.
INC. (K910860) 7. ALL-BOND 2 by BISCO, INC.
(K934690) OPTIBOND by KERR MFG.CO 8.
1. Description for the premarket notification

This product is similar and substantially equivalent in design, composition and function to the

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similar products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial.

6. Statement of the intended use

Statement of the firended aso products.

	1) Direct filling restorations using light-curing composite or compomer
a)	CLEARFIL LINER BOND 2V by KURARAY CO., LTD.	(K974486)
b)	CLEARFIL LINER BOND 2 by KURARAY CO., LTD.	(K943170)
c)	PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMELBONDING AGENT WITH ACTIVATOR by DENTSPLY	(K964525)
d)	GLUMA ONE BOND by HERAEUS KULZER, INC.	(K974390)

	2) Cavity sealing as a pretreatment for indirect restorations
a)	CLEARFIL LINER BOND 2V by KURARAY CO., LTD.	(K974486)
b)	ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM byBISCO, INC.	(K#unknown)
c)	ALL-BOND 2 by BISCO, INC.	(K910860)
d)	OPTIBOND by KERR MFG.CO	(K934690)

	3) Treatment of hypersensitive and/or exposed root surfaces
a)	CLEARFIL LINER BOND 2V by KURARAY CO., LTD.	(K974486)
b)	CLEARFIL LINER BOND 2 by KURARAY CO., LTD.	(K943170)

PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) c) BONDING AGENT WITH ACTIVATOR by DENTSPLY
ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM by (K#unknown) d) BISCO, INC.
Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or 4) composite resin using light-curing composite

a) CLEARFIL LINER BOND 2V by KURARAY CO., LTD.	(K974486)
b) PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMELBONDING AGENT WITH ACTIVATOR by DENTSPLY	(K964525)

1. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

a) CLEARFIL LINER BOND 2V by KURARAY CO., LTD.	(K974486)
b) CLEARFIL PHOTO BOND by KURARAY CO., LTD.	(K943165)

1. Statement of the technological characteristics and safety
  Buttems of the wonners great as a simplified system of CLEARFIL LINER BOND 2V permitted to be marketed (K974486). CLEARFIL SE BOND is substantially equivalent to those of products sold in the U.S. market in design, components and functions.
7-1 Components
CLEARFIL SE BOND consists of Primer, Bonding Agent, Etching Agent and accessories. These components are similar to those of the products in the paragraph 4 of this summary.

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7-2 Performance

Periormance
There is no ISO standard applicable to CLEARFIL SE BOND. The bond strengths to human There Is no too standard appricable to cl and porcelain were evaluated in comparison with enamel, numan dentife, precious mocal are performances are substantially equivalent to those of CLEARFIL LINER BOND 2V.

7-3 Chemical ingredients and safety

The chemical ingredients and bacty The chemical ingredictive have been use an in ial y equivalent to the predicated devices.

CLEARFIL LINER BOND 2V by KURARAY CO., LTD. (K974486) a) (K983361) PANAVIA F by KURARAY CO., LTD. b)
(K982164) ESTENIA by KURARAY CO., LTD. c)

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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB ! 4 1999

Kuraray Co., Ltd. C/O Mr. Koji Fujita President Kuraray America, Incorporated 30th FI Metlife Building 200 Park Avenue New York, New York 10166-3098

Re : K990040 CLEARFIL SE BOND Trade Name: Regulatory Class: II Product Code: KLE January 6, 1999 Dated: January 6, 1999 Received:

Dear Mr. Fujita:

We have reviewed your Section 510(k) notification of intent to we have reviewed your becoed above and we have determined the market the device refly equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Commerce prior co nay ents, or to devices that have been Medical Device imendance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, rood, Drug, and commons to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of Include requiremufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may (opecial ochorsuch additional controls. Existing major be subject to back accoundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulation ent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (URL) regections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vegulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Fujita

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your tial equivalence of your device to a legally Finding of substancial equires in a classification for your marketed predicate device burned to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on Jour Chilison of Small Manufacturers Assistance at its toll-free number (800) 638-20#1 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timo Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the text "K990040" in a bold, sans-serif font. Below this, the text "[CLEARFIL SE BOND, Kuraray]" is printed in a smaller, serif font. The text appears to be part of a label or product identifier.

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K990040

CLERFIL SE BOND Device Name: _

Indications For Use

CLEARFIL SE BOND is indicated for the following applications:

Ard III OL DOND is managing light-curing composite or compomer 1)

Cavity sealing as a pretreatment for indirect restorations 2)
Oavity seaming as a prositive and/or exposed root surfaces 3)
Treatment of dypersensitive andor exposed root successor
Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics and cured 4) composite resin
composite resin
Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured 5) composite resin

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

Concurrence of CDRH, Office of Device Evaluation (ODE) *** Over-The-Counter Use_ OR Prescription Use_6 (Part 21 CFR 801.109) (Optional Format 1-2-96) us not of the 1100 (Division Sign-Off) Division of The'. Infect නාවිතා and General Siot pital Develop remov 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.