K-ETCHANT GEL

K062409 · Kuraray Medical, Inc. · EBF · Nov 8, 2006 · Dental

Device Facts

• Record ID: K062409
• Device Name: K-ETCHANT GEL
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

Etching the enamel and dentine for adhesive restorations

Device Story

K-ETCHANT GEL is a dental etching agent composed of 40% phosphoric acid aqueous solution and colloidal silica. It is applied by a dental professional to the interior of a prepared tooth cavity to etch enamel and dentine, thereby improving the retention of adhesive restorations. The device is supplied as a gel for manual application. It functions as a chemical preparation step in restorative dentistry procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on chemical composition and intended use identical to legally marketed predicate devices.

Technological Characteristics

Composition: 40% phosphoric acid aqueous solution and colloidal silica. Form factor: Gel. Application: Manual painting on tooth surface. Energy source: None (chemical).

Indications for Use

Indicated for etching enamel and dentine to improve retention of adhesive dental restorations in patients requiring such procedures.

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

• CLEARFIL PHOTO BOND (K943165, K012432)
• PULPDENT ETCH-RITE ROYALE (K031915)

Submission Summary (Full Text)

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uraray

Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters appear to be 'K062409'. The writing is in black ink on a white background. The characters are somewhat stylized and have a slightly irregular appearance.

August 16, 2006 Date:

### 510(k) Summar

NOV - 8 2006

1. 510(k) owner (submitter)

| 1) Name | KURARAY MEDICAL INC. | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan | |
| 3) Contact person | Michio Takigawa<br>Quality Assurance Department | |
| 4) Contact person in U.S. | Koji Nishida<br>KURARAY AMERICA, INC.<br>600 Lexington Avenue, 26th Floor<br>New York, NY 10022<br>Tel: [phone] (Ext. 115) or (800)-879-1676<br>Fax: [phone] | |
| 2. Name of Device | | |
| 1) Trade / Proprietary name | K-ETCHANT GEL | |
| 2) Classification name | Resin tooth bonding agent | |

Resin tooth bonding agent (21 CFR section 872.3200. Product code: KLE)

3) Common narne

Etching, agent

3. Predicate device

The aim of this submission is to market K-ETCHANT GEL, which has been one of the components in CLEARFIL PHOTO BOND, independently as a single device "K-ETCHANT GEL".

| 1) CLEARFIL PHOTO BOND | 510(k) Number: | K943165<br>K012432 (modification) |
|------------------------------|------------------------------------------------------------------|----------------------------------------------------|
| | Product Code:<br>21 CFR Section:<br>Applicant: | KLE<br>872.3200<br>KURARAY MEDICAL INC. |
| 2) PULPDENT ETCH-RITE ROYALE | 510(k) Number:<br>Product Code:<br>21 CFR Section:<br>Applicant: | K031915<br>KLE<br>872.3200<br>PULPDENT CORPORATION |

4. Description of device

K-ETCHANT GEL is an etching agent consists of 40 % phosphoric acid aqueous solution and colloidal silica. It is classified into resin tooth honding agent, 21 CFR Section 872.3200, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.

- 5. Intended use
K-ETCHANT GEL is intended to be used for the following indication;

- Etching the enamel and dentine for adhesive restorations

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#### 6. Substantial equivalence

K-ETCHANT GEL has been one of the components in, and will be marketed independently as a single device "K-ETCHATN GEL" from CLEANFIL PHOTO BOND. The applicant device, is essentially the same as K-ETCHANT GEL in CLEARFIL PHOTO BOND that its safety and effectiveness are substantially equivalent to this predicate device. It shares the same intended use with other legally marketed devices of this kind marketed single item such as PULPDENT ETCH-RITE ROYALE.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical, Incorporated C/O Mr. Koji Nishida General Manager Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022

NOV -8 2006

Re: K062409

Trade/Device Name: K-ETCHANT GEL Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 16, 2006 Received: August 24, 2006

Dear Mr. Nishida:

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.

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#### Page 2 -Mr. Nishida

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. 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 (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ر

Device Name: _K-ETCHANT GEL_

Indications for Use:

1) Etching the enamel and dentine for adhesive restorations.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/CPR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use N/A (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control. D

510(k) Number: k062409