This product is classified into Caries Detection Device, CFR 21 Section 872. 1740. Two of the predicate devices listed in section 3 operate by means of applying dyes to teeth to stain areas of decay. They do not involve chemical reactions, nor use electrical current or optical instruments. The methods of operation of these devices is similar to that of plaque disclosing agents in that they stain the affected areas.

AI/ML Overview

The provided text is a 510(k) summary for the "CARIES DETECTOR" device by Kuraray Medical Inc. It explicitly states that the submission is for an alteration of the name and address of the manufacturer and not to intend other changes to the device itself.

It further clarifies that the "technological characteristics, chemical ingredients and safety of this device are completely the same as CARIES DETECTOR manufactured by Kuraray Co., Ltd. (K951813)."

This means that a new study to prove device performance or establish new acceptance criteria was not conducted for this specific 510(k) submission (K012733). The substantial equivalence is based on the predicate device (K951813), which presumably had its performance proven at the time of its own clearance.

Therefore, the requested information regarding acceptance criteria and the study proving the device meets them cannot be directly extracted from this document for K012733, as no such new study was performed for this submission. The document relies on the previous clearance of the predicate device.

To answer your request, one would need to refer to the original 510(k) submission for the predicate device, K951813 (CARIES DETECTOR by Kuraray Co., Ltd.), if that information is publicly available.

Based solely on the provided text for K012733:

Table of acceptance criteria and the reported device performance:
- No new acceptance criteria or reported device performance studies are included in this 510(k) summary for K012733, as it is a manufacturer name/address change and not a device modification. The device is stated to be "completely the same" as the predicate K951813.
Sample size used for the test set and the data provenance:
- Not applicable to this 510(k) submission, as no new performance study was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this 510(k) submission, as no new performance study was conducted.
Adjudication method:
- Not applicable to this 510(k) submission, as no new performance study was conducted.
Multi-reader multi-case (MRMC) comparative effectiveness study:
- No MRMC study was conducted or reported in this 510(k) submission.
Standalone performance study:
- No standalone performance study was conducted or reported in this 510(k) submission for K012733.
Type of ground truth used:
- Not applicable to this 510(k) submission, as no new performance study was conducted.
Sample size for the training set:
- Not applicable to this 510(k) submission, as it is a dye-based caries detection device and typically does not involve algorithm training in the context of AI.
How the ground truth for the training set was established:
- Not applicable to this 510(k) submission.

Summary

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KURARAY MEDICAL 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 letter "K" is enclosed within a black square. Below the "K" is the word "KURARAY" in a simple sans-serif font.

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

KO12733

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 YorkNY 10166Telephone : (212)-986-22301-(800)-879-1676Facsimile : (212)-867-3543

2. Name of Device

1) Proprietary Name	CARIES DETECTOR
2) Classification Name	Caries Detection Device (21 C.F.R. Section 872. 1740)
3) Common/Usual Name	Caries Detection Device

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.

1.	CARIES DETECTOR by Kuraray Co., Ltd.	(K951813)
2.	Kar-D-Tek by Gresco Products Inc.	(K913405)

Kar-D-Tek by Gresco Products Inc. 2.
1. Description for the premarket notification

This product is classified into Caries Detection Device, CFR 21 Section 872. 1740.

Two of the predicate devices listed in section 3 operate by means of applying dyes to teeth to stain areas of decay. They do not involve chemical reactions, nor use electrical current or optical instruments. The methods of operation of these devices is similar to that of plaque disclosing agents in that they stain the affected areas.

1. Statement of the intended use
  The intended use of this device is as follow. It is completely the same as CARIES DETECTOR

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manufactured by Kuraray Co., Ltd. (K951813).

Detection of carious dentin

1. Statement of the technological characteristics and safety
  tatement of the toolinsion in clicities DETECTOR manufactured by Kuraray Co., Ltd. The device is essentially as a characteristics, chemical ingredients and safety of this device are completely the same as CARIES DETECTOR.

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.

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: K012733

Trade/Device Name: Caries Detector Regulation Number: 872.1740 Regulation Name: Caries Detection Device Regulatory Class: II Product Code: LFC 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. 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,

[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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510(k) Number (if known): __ KO/2733

K012733

Device Name: CARIES DETECTOR

Indications for Use

CARIES DETECTOR is indicated for the following applications: Detection of carious dentin 1)

(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

§ 872.1740 Caries detection device.

(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.