Direct filling restorations using light-cure or chemical-cure composite resin 1)
1. Bonded amalgam restorations
1. Treatment of hypersensitive and/or exposed root surfaces
Cavity sealing as a pretreatment for indirect restorations 4)
1. Intraoral repairs of facing crowns using light-cure composite resin
1. Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement

Device Description

CLEARFIL LINER BOND 2V 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. PROTECT LINER F is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of material such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. CLEARFIL PORCELAIN BOND ACTIVATOR was permitted to market under its 510(k) notification submission.

AI/ML Overview

This document is a 510(k) summary for a dental material, CLEARFIL LINER BOND 2V. It primarily focuses on an administrative change regarding the manufacturer's name and address, stating that the device itself is essentially the same as a previously cleared predicate device (K974486).

Therefore, the information typically requested regarding acceptance criteria and a study proving a novel device meets those criteria is not present in this document. This submission is for an administrative change, not a new device.

Here's a breakdown of why the requested information cannot be provided from this document:

A table of acceptance criteria and the reported device performance: This document does not present any specific performance data or acceptance criteria because it's a notification about an organizational change, not a new product with new performance claims. The device is being cleared based on its substantial equivalence to a predicate device, which implies its performance aligns with that predicate without requiring new testing for this specific submission.
Sample size used for the test set and the data provenance: No test set is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no new test set.
Adjudication method for the test set: Not applicable.
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 a dental material, not an AI-based diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant or included.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a dental material.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as this is a dental material, not an algorithm.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The 510(k) summary explicitly states:

"The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes." (Section 3)
"This device is essentially the same as CLEARFIL LINER BOND 2V manufactured by Kuraray Co., Ltd. (K974486). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL LINER BOND 2V." (Section 6)

This means that the device is not undergoing new performance testing for this submission. Its "acceptance criteria" and "proof of meeting them" would have been established during the original 510(k) clearance (K974486) for the predicate device, which is not detailed here. The current submission relies on the established equivalence to that predicate.

Summary

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SEP - 5 2001

[CLEARFIL LINER BOND 2V, Kuraray Medical Inc.]

KURARAY MEDICAL INC.

KO12440

Image /page/0/Picture/4 description: The image is a logo for Kuraray. The logo is a black square with a white stylized "K" inside. The "K" is made up of geometric shapes, and the word "KURARAY" is printed in white below the "K". The logo is simple and modern.

Dental Material Department 12-39. 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN : +81-6-348-2603 Facsimile: +81-6-348-2552

510(k) SUMMARY

1. Submitter

1)	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-8622, Japan
3) Contact person	Koji Nishida
	DENTAL MATERIAL DEPARTMENT
4) Date	July 23, 2001
5) Contact person in U.S.A.	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 LINER BOND 2V
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.

(K974486) CLEARFIL LINER BOND 2V 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 LINER BOND 2V manufactured by Kuraray Co., Ltd. (K974486).

1. Direct filling restorations using light-cure or chemical-cure composite resin
1. Bonded amalgam restorations
1. Treatment of hypersensitive and/or exposed root surfaces
1. Cavity sealing as a pretreatment for indirect restorations
1. Intraoral repairs of facing crowns using light-cure composite resin
1. Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement
1. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL LINER BOND 2V manufactured by Kuraray Co., Ltd. (K974486). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL LINER BOND 2V.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2001

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

K012440 Re : Modification To Clearfil Liner Trade/Device Name: Bond 2V 872.3200 Requlation Number: II Requlatory Class: Product Code: KLE Dated: Jul 23, 2001 Received: July 31, 2001

Dear Ms. Sasaki:

We have reviewed your Section 510(k) notification of intent to we have reviewed referenced above and we have determined the market the abrantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the choiobane commerce prior to May 28, 1976, devices mariesoa of the Medical Device Amendments, or to the enacement acobeen reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 provision, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ್ಗೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Ms. Sasaki

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ent affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic enroagn Siz or or or on control provisions, or other Federal laws or requlations.

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 markees probles, permits your device 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) 594-4613. 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. 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLEARFIL LINER BOND 2V

Indications for Use

CLEAFIL LINER BOND 2V is indicated for the following applications:

Direct filling restorations using light-cure or chemical-cure composite resin 1)
1. Bonded amalgam restorations
1. Treatment of hypersensitive and/or exposed root surfaces
Cavity sealing as a pretreatment for indirect restorations 4)
1. Intraoral repairs of facing crowns using light-cure composite resin
1. Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement

(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 of Dental, Infection Control, and General Hospital Devices ******************************************************************************************************************************************************************************

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.