ESTENIA

K012707 · Kuraray Medical, Inc. · EBF · Sep 13, 2001 · Dental

Device Facts

• Record ID: K012707
• Device Name: ESTENIA
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

ESTENIA is used for the following cases: 1) Jacket crown 2) Facing crown 3) Inlay and onlay

Device Story

ESTENIA is a resin-based crown and bridge material used for laboratory fabrication of dental restorations; specifically jacket crowns, facing crowns, inlays, and onlays. Composed of dimethacrylate monomers and inorganic fillers. Used by dental laboratory technicians to create custom dental prosthetics. The device is a material, not an automated system; it does not involve software, algorithms, or digital processing. It serves as a restorative material for dental professionals to improve patient oral function and aesthetics.

Clinical Evidence

No clinical data; bench testing only. The device is identical to the predicate.

Technological Characteristics

Resin-based crown and bridge material composed of dimethacrylate monomers and inorganic fillers. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for laboratory fabrication of jacket crowns, facing crowns, inlays, and onlays.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 : [phone] Phone Facsimile: [phone]

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 : [phone] |
| | 1-(800)-879-1676<br>Facsimile : (212)-867-3543 |

#### 2. Name of Device

| <b>1) Proprietary Name</b> | ESTENIA |
|-------------------------------|---------------------------------------------|
| <b>2) Classification Name</b> | Tooth shade resin material (21CFR 872.3690) |
| <b>3) Common/Usual Name</b> | 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.
- 4. Description for the premarket notification

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.

- 5. 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
2) Facing crown

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#### 3) Inlay and onlay

- 6. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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. ]

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510(k) Number (if known):

Device Name: ESTENIA

# Indications for Use

ESTENIA is used for the following cases:

Jacket crown 1)

Facing crown 2)

3) 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

OR

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____________________________________________________________________________________________________________________________________