CLEARFIL DC CEMENT is a dual-cure composite resin cement and used as a cement to affix dental appliances such as crowns. This product is classified into the dental cement other than zinc oxide-eugenol, 21 C.F.R. Section 872.3275.

AI/ML Overview

The provided document is a 510(k) summary for a dental device, "CLEARFIL DC CEMENT." This document focuses on a change in manufacturer and asserts that the device is "substantially equivalent" to a previously cleared predicate device (K980232).

Crucially, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data analysis.

The 510(k) submission states that: "This device is essentially the same as CLEARFIL DC CEMENT manufactured by Kuraray Co., Ltd. (K980232). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL DC CEMENT." This implies that the performance data from the predicate device's clearance would be referenced, but no such data, acceptance criteria, or study details are present in this specific document.

Therefore, I cannot provide the requested information from this document. If these details were available, they would typically be found in sections describing performance testing, clinical studies, or bench testing results which are absent here.

Summary

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

DICAL INC. URARAY MEL

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

KOI2735

SEP 1 4 2001

510(k) SUMMARY

1. Submitter
1) Name	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-8622, Japan
3) Contact person	Koji NishidaDENTAL MATERIAL DEPARTMENT
4) Date	August 9, 2001
5) Contact person in U.S.A.	Masaya Sasaki30th Fl. Metlife Building, 200 Park Avenue, New York,NY 10166Telephone : (212)-986-22301-(800)-879-1676Facsimile : (212)-867-3543

2. Name of Device

1) Proprietary Name	CLEARFIL DC CEMENT
2) Classification Name	Dental cement (21 C.F.R. Section 872.3275)
3) Common/Usual Name	Composite resin cement

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 October 1st 2001. The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes.

The predicate device is as follow.

(K980232) CLEARFIL DC CEMENT by Kuraray Co., Ltd. 1.

4. Description for the premarket notification

CLEARFIL DC CEMENT is a dual-cure composite resin cement and used as a cement to This product is classified into the dental cement affix dental appliances such as crowns. other than zinc oxide-eugenol, 21 C.F.R. Section 872.3275.

5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as CLEARFIL DC CEMENT manufactured by Kuraray Co., Ltd. (K980232).

1)Porcelain inlay cementation
1. Composite resin inlay cementation

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3)Jacket crown cementation with porcelain or composite resin

6. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL DC CEMENT manufactured by Kuraray Co., Ltd. (K980232). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL DC CEMENT.

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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 image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.

Public Health Service

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: K012735

Trade/Device Name: Clearfil DC Cement Regulation Number: 872.3275 Regulation Name: Composite Resin Cement Regulatory Class: II Product Code: EMA Dated: August 9, 2001 Received: August 14, 2001

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 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 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.

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.

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Page 2 - Ms. Sasaki

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,

U. Adalbert

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): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

K012735

Device Name: CLEARFIL DC CEMENT

Indications for Use

CLEARFIL DC CEMENT is indicated for the following applications:

Porcelain inlay cementation 1)
Composite resin inlay cementation 2)
Jacket crown cementation with porcelain or composite resin 3)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use_

(Optional Format 1-2-96)

Susan Runne

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

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.