SURFACE COAT

K063228 · Kuraray America, Inc. · EBD · Dec 8, 2006 · Dental

Device Facts

• Record ID: K063228
• Device Name: SURFACE COAT
• Applicant: Kuraray America, Inc.
• Product Code: EBD · Dental
• Decision Date: Dec 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SURFACE COAT, the applicant device, is used to glaze/polish following restorations: - Direct and indirect composite resins - Acrylic provisional crowns and bridges - Acrylic appliances - Glass ionomers and resin-modified glass ionomers

Device Story

SURFACE COAT is a single-component, light-cure resin glaze material; applied to dental restorations to provide a clear, smooth surface finish. Device eliminates or reduces need for manual polishing; features minimal surface oxygen inhibition layer. Used by dental professionals in clinical settings to treat composite resins, acrylic crowns/bridges, acrylic appliances, and glass ionomers. Benefits patient by improving surface aesthetics and durability of dental restorations.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated by comparing device specifications against predicate devices.

Technological Characteristics

Single-component, light-cure resin glaze. Composition: multi-functional acrylate monomer. Form factor: liquid resin. Polymerization: light-cure. No specific ASTM standards cited.

Indications for Use

Indicated for glazing and polishing direct/indirect composite resins, acrylic provisional crowns/bridges, acrylic appliances, and glass ionomer/resin-modified glass ionomer restorations.

Regulatory Classification

Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Predicate Devices

• BISCOVER LIQUID POLISH (K030354)
• BISCOVER LV (K043168)
• C&B METABOND (K960464)
• CHROMA ZONE COLOR STAIN (K012737)
• PANAVIA F 2.0 (K032455)

Submission Summary (Full Text)

{0}------------------------------------------------

K063228

DEC - 8 2006

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

ノ

October 24, 2006 Date:

-

।

# 510(k) Summary

1. 510(k) owner (submitter)

ﺑ

୍ୟ

. .

| 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 | SURFACE COAT | |
| 2) Classification name | Coating, Filling Material, Resin<br>(21 CFR section 872.3310. Product code: EBD) | |
| 3) Common name | Resin glaze material | |
| 3. Predicate device | | |
| 1) BISCOVER LIQUID POLISH | 510(k) Number:<br>Product Code:<br>21 CFR Section:<br>Applicant: | K030354<br>EBD<br>872.3310<br>BISCO, INC. |
| 2) BISCOVER LV | 510(k) Number:<br>Product Code:<br>21 CFR Section:<br>Applicant: | K043168<br>EBD<br>872.3310<br>BISCO, INC. |
| 3) C&B METABOND | 510(k) Number:<br>Product Code:<br>21 CFR Section:<br>Applicant: | K960464<br>EMA<br>872.3275<br>PARKELL, INC. |

| 4) CHROMA ZONE COLOR STAIN | 510(k) Number:<br>Product Code:<br>21 CFR Section:<br>Applicant: | K012737<br>EBF<br>872.3690<br>KURARAY MEDICAL, INC. |
|----------------------------|------------------------------------------------------------------|-----------------------------------------------------|
| 5) PANAVIA F 2.0 | 510(k) Number:<br>Product Code:<br>21 CFR Section:<br>Applicant: | K032455<br>EMA<br>872.3275<br>KURARAY MEDICAL, INC. |

3-1

### KURARAY MEDICAL INC.

.

Quality Assurance Department

{1}------------------------------------------------

- 4. Description of device
SURFACE COAT is a single-component, light-cure resin glaze material that provides a clear and smooth surface, consisting of a multi-functional acrylate monomer that provides excellent durability and may reduce or even eliminate the need for manual polishing. SURFACE COAT has virtually no surface oxygen inhibition layer.

5. Intended use

SURFACE COAT, the applicant device, is used to glaze/polish following restorations:

- Direct and indirect composite resins
- Acrylic provisional crowns and bridges
- Acrylic appliances
- Glass ionomers and resin-modified glass ionomers

SURFACE COAT shares the same intended use as those included in the intended uses of BISCOVER LIQUID POLISH and BISCOVER LV, the predicate devices. SURFACE COAT is indicated for more limited uses than the predicate devices, as it is not used for enamel.

- 6. Substantial equivalence
The safety and effectiveness of SURFACE COAT, the applicant device, are equivalent to the predicate devices.

- 1) Effectiveness / Performance
Since there is no applicable FDA's recognized standard or international standard concerning performance of this type of device, certain specifications are designed for SURFACE COAT, the applicant device, and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent to the predicate devices in terms of the effectiveness and performance.

- 2) Safety
SURFACE COAT, the applicant device, contains chemical ingredients which have been used in the predicate devices and copes with any possible risk in a similar manner as the predicate devices suggesting the safety of the applicant device is substantially equivalent to the predicate devices.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2006

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

Re: K063228

Trade/Device Name: Surface Coat Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: October 24, 2006 Received: October 31, 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.

.

{3}------------------------------------------------

### Page 2 - Mr. Koji 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" (21 CFR 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,

Smitte y. Michael Davis.

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

06 3228 510(k) Number (if known):

Device Name: __SURFACE COAT

Indications for Use:

SURFACE COAT is used to glaze/polish following restorations:

- Direct and indirect composite resins
- Acrylic provisional crowns and bridges
- Acrylic appliances
- Glass ionomers and resin-modified glass ionomers

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

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

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Dunne

ි වෙන්වන A. Dona

KD630235