CHROMA ZONE COLOR STAIN is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations.

AI/ML Overview

The provided document is a 510(k) summary for a dental product called "CHROMA ZONE COLOR STAIN." This document pertains to a regulatory submission for a medical device and does not contain information about studies proving the device meets acceptance criteria in the context of an AI/ML medical device.

The 510(k) summary is primarily concerned with establishing substantial equivalence to a predicate device for regulatory purposes. It explicitly states: "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes" and "Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CHROMA ZONE COLOR STAIN manufactured by Kuraray Co., Ltd. (K982259)."

Consequently, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a conventional dental material, not an AI-powered diagnostic or therapeutic device.

Summary

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Image /page/0/Picture/0 description: The image is a logo for Kuraray. The logo is a black square with a white stylized "K" inside. The word "KURARAY" is written in white below the "K". The logo is simple and modern.

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

KOIZ737

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 Nishida
	DENTAL MATERIAL DEPARTMENT
4) Date	August 9, 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	CHROMA ZONE COLOR STAIN
2) Classification Name	Tooth shade resin material (21CFR 872.3690)
3) Common/Usual Name	Resin-based stain material

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.

CHROMA ZONE COLOR STAIN by Kuraray Co., Ltd. (K982259) 1.
1. Description for the premarket notification

5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as CHROMA ZONE COLOR STAIN manufactured by Kuraray Co., Ltd. (K982259).

This product is designed to be used for developing color characterization for resin-based:

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Facing crown 2) Jacket crown 3) Inlay and Onlay

1. Statement of the technological characteristics and safety
  tatomor of the vecances Therefore the technological characteristics, chemical Kuraray Co., Ltd. (K982259). ingredients and safety of this device are completely the same as CHROMA ZONE COLOR STAIN.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

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: K012737

Trade/Device Name: Chroma Zone Color Stain Regulation Number: 872.3690 Regulation Name: Resin-Based Stain Material 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

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Page 2 - Ms. Sasaki

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I edelar bates and systements, including, but not limited to: registration You must comply with an the Hec b roq 21 CFR Part 801); good manufacturing practice allu listing (21 CF RT rut 007), accling (QS) regulation (21 CFR Part 820); and if requirements as sectorar in als qualify the 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) I mis letter will anow you to began finding of substantial equivalence of your device to a premarket nonmeation: - The PD Finishers 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 If you desire specific da for in vitro diagnostic devices), please contact the Office of and additionally 6091594-4613. Additionally, for questions on the promotion and Compilance at (301) 59 re please contact the Office of Compliance at (301) 594-4639. advertibing or your aregulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the notification (210) R 00177). Case grand 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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): Device Name: CHROMA ZONE COLOR STAIN

KOIZ73

Indications for Use

CHROMA ZONE COLOR STAIN is designed to be used for developing color characterization for resin-based:

Facing crown 1)
Jacket crown 2)
Inlay and Onlay 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 Dunne

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

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.