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 or composite resin using light-curing composite
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 retention of restorative materials.

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a dental adhesive (CLEARFIL SE BOND), which focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes. It does not describe a study that involves acceptance criteria for device performance in the context of diagnostic accuracy, AI, or human reader effectiveness.

Therefore, I cannot extract the information required to answer your request, such as a table of acceptance criteria and reported device performance related to a diagnostic study, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Summary

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RARAY MEDICAL INC.

Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" inside of a square. The word "KURARAY" is written in block letters below the square.

Dental Material Department Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN +81-6-348-2603 Facsimila- +81-6-348-2552

K012442

SEP 1 0 2001

510(k) SUMMARY

1. Submitter

1. Name

Date

1. Address
1. Contact person

Contact person in U.S.A.

KURARAY MEDICAL INC. 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan Koji Nishida DENTAL MATERIAL DEPARTMENT July 23, 2001 Masaya Sasaki 30th Fl. Metlife Building, 200 Park Avenue, New York, NY 10166 Telephone : (212)-986-2230 1(800)-879-1676 Facsimile : (212)-867-3543

2. 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

3. Predicate device:

Kuraray Co., Ltd. will transfer the medical device business and the relevant functions including manufacturing facilities to its subsidiary company named Kuraray Medical Inc. on The aim of 510(k) submission is to alter the name and address of October 1st 2001. manufacturer, and not to intend other changes.

The predicate device is as follow.

CLEARFIL SE BOND by Kuraray Co., Ltd. (K990040) 1.

4. Description for the premarket notification

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1. Statement of the intended use
  The intended uses of this device are as follows. They are completely the same as CLEARFIL SE BOND manufactured by Kuraray Co., Ltd. (K990040).
1. Direct filling restorations using light-curing composite 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 facing crowns made of porcelain, hybrid ceramics or comosite resin using light-curing composite
1. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
1. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL SE BOND manufactured by Kuraray Co., td. (K990040). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL SE BOND.

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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 symbol that resembles three overlapping human profiles or abstract shapes, possibly representing people or interconnectedness.

Public Health Service

SEP 1 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue New York, New York 10166

Re: K012442

Trade/Device Name: Modification To Clearfil SE Bond Regulation Number: 872.3200 Regulation Name: Resin-Based Dental Adhesive System Regulatory Class: II Product Code: KLE Dated: July 23, 2001 Received: July 31, 2001

Dear Ms. Sasaki:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Anonoments, or to active and Cosmetic Act (Act) that do not require approval of a premarket the rouchal application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your 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 (1 wr ), it may of buryed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in farther announcements concerning your device in the Federal Register.

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

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Page 2 - Ms. Sasaki

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Timothy A. Jlatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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[CLEARFIL SE BOND, Kuraray Medical Inc.]

K012442

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLEARFIL SE BOND

Indications for Use

CLEAFIL SE BOND is indicated for the following applications:

Direct filling restorations using light-curing composite or compomer 1)
Cavity sealing as a pretreatment for indirect restorations 2)
Treatment of hypersensitive and/or exposed root surfaces 3)
Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite 4) resin using light-curing composite
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)

Prescription Use_ V (Part 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Russe

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devic 510(k) Number -

ADVIN

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.