CLEARFIL NEW BOND is classified into Resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. Normally composite resins and amalgams are used as filling material for this purpose.

AI/ML Overview

The provided text is a 510(k) summary for a dental adhesive system called CLEARFIL NEW BOND. It describes the device, its intended use, and states that it is essentially the same as a previously cleared predicate device (K943167).

However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a submission to the FDA seeking clearance based on substantial equivalence to an existing device, not a report of performance testing against specific criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance: Not present.
Sample size used for the test set and the data provenance: Not present, as no performance test is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
Adjudication method for the test set: Not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
If a standalone performance study was done: Not present.
The type of ground truth used: Not present.
The sample size for the training set: Not present, as this is not an AI/algorithm-based device and no training set is mentioned.
How the ground truth for the training set was established: Not present.

The document focuses on:

Identifying the submitter and device.
Classifying the device.
Stating its equivalence to a predicate device (K943167).
Describing its intended use (dental bonding agent).
Asserting that its technological characteristics, chemical ingredients, and safety are "completely the same" as the predicate device.

The FDA's letter (pages 2-3) confirms their review of the submission and their determination of "substantial equivalence" to legally marketed predicate devices. This substantial equivalence determination is the basis for clearance, rather than a new performance study to meet specific acceptance criteria for a novel device.

Summary

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DICAL INC.

Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" that is formed by a combination of straight and curved lines. The word "KURARAY" is printed in a simple sans-serif font below the letter "K". The logo is simple and modern.

tal Material Department Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN +81-6-348-2603 Facsimile: +81-6-348-2552

SEP 1 4 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 August 9, 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 NEW 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.

(K943167) CLEARFIL NEW BOND by Kuraray Co., Ltd. 1.

4. Description for the premarket notification

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5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as CLEARFIL NEW BOND manufactured by Kuraray Co., Ltd. (K943167).

A dentin and enamel bonding system for composite resin restoration 1)
A dentin and enamel bonding system for amalgam restoration 2)

6. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL NEW BOND manufactured by Kuraray Co., Therefore the technological characteristics, chemical ingredients and safety of Ltd. (K943167). this device are completely the same as CLEARFIL NEW 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle are three stylized human profiles facing to the right, with flowing lines representing hair or clothing.

SEP 1 4 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: K012734

Trade/Device Name: Clearfil New Bond Regulation Number: 872.3200 Regulation Name: Resin-Based Dental Adhesive System Regulatory Class: II Product Code: KLE Dated: August 9, 2001 Received: August 14, 2001

Dear Mr. 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinently, or to are road Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 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 mr.), it is a 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.

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. of the rect or unly 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 and ilouing (21 cert forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquirelients as lectronic 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) rms reter wrification. 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.

les Alatort

Timothy A. Ulatowski 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 NEW BOND, Kuraray Medical Inc.]

K012734

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLEARFIL NEW BOND

Indications for Use

CLEAFIL NEW BOND is indicated for the following applications:

1. A dentin and enamel bonding system for composite resin restoration
A dentin and enamel bonding system for amalgam restoration 2)

(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)

Susan Runner

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division oral Hospital De 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.