This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.

AI/ML Overview

This is a 510(k) premarket notification for a dental material (CLEARFIL AP-X), not a medical device that would involve a study with acceptance criteria in the typical sense (performance metrics, ground truth, expert review, etc.).

The submission focuses on a change of manufacturer name and address for an already cleared device (predicate device K943168). Therefore, the provided documentation explicitly states that:

"The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes."
"This device is essentially the same as CLEARFIL AP-X manufactured by Kuraray Co., Ltd. (K943168). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL AP-X."

This means there's no new study conducted to establish acceptance criteria or demonstrate device performance for this specific 510(k) submission (K012740). The acceptance of this submission is based on the substantial equivalence to the predicate device, which has already met its regulatory requirements.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable to this specific 510(k) submission as it is merely an administrative change.

Summary

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KURARAY MEDICAL INC.

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

K012740

SEP 1 4 2001

510(k) SUMMARY

1. Submitter
- 1. Name
- 1. Address
- 1. Contact person

Date

KURARAY MEDICAL INC. 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan Koji Nishida DENTAL MATERIAL DEPARTMENT August 9, 2001 Masaya Sasaki 5) Contact person in U.S.A. 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 AP-X
2) Classification Name	Tooth shade resin material (21CFR 872.3690)
3) Common/Usual Name	Composite resin restorative

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 AP-X by Kuraray Co., Ltd. (K943168) 1.
1. Description for the premarket notification

1. Statement of the intended use
  The intended uses of this device are as follows. They are completely the same as CLEARFIL AP-X manufactured by Kuraray Co., Ltd. (K943168).
Class I, II, V restorations of posterior teeth 1)
Class III, IV, V restorations of anterior teeth 2)
Cervical cavities or defects involving root surfaces 3)

6. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL AP-X manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of this (K943168).

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device are completely the same as CLEARFIL AP-X.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the circumference of the circle.

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: K012740

Trade/Device Name: Clearfil AP-X Regulation Number: 872.3690 Regulation Name: Composite Resin Restorative Regulatory Class: II Product Code: EBF 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 and insing (s 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,

[signature]

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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KO1274-O

510(k) Number (if known): _ KOLZZZ4

Device Name: CLEARFIL AP-X

Indications for Use

CLEARFIL AP-X is indicated for the following applications:

Class I, II, V restorations of posterior teeth
Class III, IV, V restorations of anterior teeth
Cervical cavities or defects involving root surfaces

(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 12741 510(k) Number _

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Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.