ESTENIA 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, inlay and onlay restorations.

AI/ML Overview

The provided document is a 510(k) summary for a dental material called ESTENIA. It states that the submission aims to alter the manufacturer's name and address, and not to intend other changes to the device itself. Therefore, the device's technological characteristics, chemical ingredients, and safety are completely the same as the predicate device (K982164).

This means the submission does not contain a new study demonstrating that the device meets acceptance criteria because it is essentially a rebranding/transfer of ownership of an already approved device. The "acceptance criteria" and "study" would have been part of the previous 510(k) submission (K982164) for the original ESTENIA device by Kuraray Co., Ltd.

Based on the provided document, the following information cannot be extracted because no new study was conducted for this specific 510(k) submission:

A table of acceptance criteria and the reported device performance: Not provided. The document explicitly states the device is identical to the predicate.
Sample size used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental material, not an AI or imaging device with human reader interaction.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material.
The type of ground truth used: Not provided.
The sample size for the training set: Not applicable. This device is a dental material, not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission relies on the substantial equivalence principle, asserting that the device (ESTENIA by Kuraray Medical Inc.) is identical to its predicate device (ESTENIA by Kuraray Co., Ltd., K982164). Therefore, no new efficacy or performance studies are presented in this document.

Summary

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SEP 1 3 2001

Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically 'KO12707'. The characters are written in a clear, sans-serif font, with a consistent stroke width. The text appears to be a code or identifier, possibly a serial number or product code.

Image /page/0/Picture/3 description: The image is a logo for Kuraray. The logo is a black square with a white stylized letter "K" inside. The word "KURARAY" is written in white letters below the "K" inside the black square.

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

KURARAY MEDICAL INC.

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)-879-1676Facsimile : (212)-867-3543

2. Name of Device

1) Proprietary Name	ESTENIA
2) Classification Name	Tooth shade resin material (21CFR 872.3690)
3) Common/Usual Name	Resin-based crown and bridge 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.

(K982164) ESTENIA by Kuraray Co., Ltd. 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 ESTENIA manufactured by Kuraray Co., Ltd. (K982164).

ESTENIA is used for the following cases:

1)Jacket crown

Facing crown

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3) Inlay and onlay

1. Statement of the technological characteristics and safety
  This device is essentially the same as ESTENIA manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of (K982164). this device are completely the same as ESTENIA.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, creating a sense of depth and unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2001

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

Re: K012707

Trade/Device Name: Estenia Regulation Number: 872.3690 Regulation Name: Resin-Based Crown and Bridge 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. 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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[ESTENIA, Kuraray Medical Inc. ]

Image /page/4/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the digit '0', then the digit '1', then the digit '2', then the digit '7', then the digit '0', and ends with the digit '7'. The characters are written in a simple, clear style, and they appear to be part of a larger document or label.

510(k) Number (if known):

Device Name: ESTENIA

Indications for Use

ESTENIA is used for the following cases:

Jacket crown 1)

Facing crown 2)

Inlay and onlay

(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 Runore

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

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.