CLEARFIL ESTHETIC CEMENT & DC BOND

K062410 · Kuraray Medical, Inc. · EMA · Sep 26, 2006 · Dental

Device Facts

• Record ID: K062410
• Device Name: CLEARFIL ESTHETIC CEMENT & DC BOND
• Applicant: Kuraray Medical, Inc.
• Product Code: EMA · Dental
• Decision Date: Sep 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, hybrid ceramics, composite resin or metal Cementation of veneers Cementation of adhesion bridges Cementation of metal cores, resin cores, metal posts or glass-fiber posts

Device Story

CLEARFIL ESTHETIC CEMENT & DC BOND is a dental composite resin cement system used by dentists for permanent cementation of various indirect restorations (crowns, bridges, inlays, onlays, veneers, posts). The system functions as a luting agent to bond restorative materials—including porcelain, ceramic, hybrid ceramics, composite resin, and metal—to tooth structure. It is applied in a clinical setting by dental professionals. The device facilitates the secure attachment of prosthetics, improving structural integrity and retention of the restoration, thereby restoring dental function and aesthetics for the patient.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was evaluated through laboratory testing of physical and mechanical properties to demonstrate equivalence to predicate devices.

Technological Characteristics

Dual-cure composite resin cement system. Materials include resin monomers, fillers, and catalysts typical of dental luting cements. Polymerization is achieved via chemical and/or light-curing mechanisms. Form factor is a multi-component system for mixing and application. No electronic components or software.

Indications for Use

Indicated for the cementation of crowns, bridges, inlays, onlays, veneers, adhesion bridges, metal cores, resin cores, metal posts, or glass-fiber posts in patients requiring dental restorative procedures.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• PANAVIA F 2.0 (K032455)
• CLEARFIL DC CEMENT (K012735)
• CLEARFIL DC CORE AUTOMIX (K043177)

Submission Summary (Full Text)

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

I. INTRODUCTION

ﯿﻮ ﻣﮩﺮ ﺳ

[CLEARFIL ESTHETIC CEMENT & DC BOND, KURARAY MEDICAL INC.] Section 3: Summary

# 1062410

Aug 16, 2006

## 510(k) Summary

SEP 26 2006

#### 3-1. 510(k) owner (submitter)

1) Name

2) Address

3) Contact person

4) Contact person in U.S.

#### KURARAY MEDICAL INC.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

Koji Nishida KURARAY AMERICA INC. 600 Lexington Avenue, 26th Floor New York, NY 10022 Tel: [phone] (Ext. 115) or (800)-879-1676 Fax: [phone]

#### 3-2. Name of Device

1) Trade / Proprietary name

2) Classification name

3) Common name

#### 3-3. Predicate device

1) PANAVIA F 2.0

#### CLEARFIL ESTHETIC CEMENT & DC BOND

Dental cement (21 CFR section 872.3275. Product code: EMA)

Composite resin cement

510(k) Number: Product Code: 21 CFR Section: Applicant:

K032455 EMA 872.3275 KURARAY MEDICAL INC.

#### 2) CLEARFIL DC CEMENT

510(k) Number: Product Code: 21 CFR Section: Applicant:

K012735 EMA 872.3275 KURARAY MEDICAL INC.

#### 3) CLEARFIL DC CORE AUTOMIX

510(k) Number: Product Code: 21 CFR Section: Applicant:

K043177 EBF 872.3690 KURARAY MEDICAL INC.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP 2 6 2006

Re: K062410

Trade/Device Name: Clearfil™ Esthetic Cement & DC Bond Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA 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 Coometic Act (Act) that do not require approval of a premarket approval application (PMA). You may n 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 devines , 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 it (112), 1 be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA meet publish further announcements concerning your device in the Federal Register.

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

### Page 2 – Mr. Koji Nishida

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r touse be advisound a determination that your device complies with other requirements of the Act or that Federal statutes and regulations administered by other Federal agencies. You must comply with all 1 castle statution and to got 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 iabeling (2) cregulation (2) 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 devise .in-your.Section 510(k) rms let notification. The FDA finding of substantial equivalence of your device to a legally premated 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 Echedi missimational 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 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

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

# Indications for Use

KO62410 510(k) Number (if known):

Device Name: CLEARFIL ESTHETIC CEMENT & DC BOND

Indications for Use:

- 1) Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, hybrid ceramics, composite resin or metal
- 2) Cementation of veneers
- 3) Cementation of adhesion bridges
- 4) Cementation of metal cores, resin cores, metal posts or glass-fiber posts

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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)

Sen
Sign-Or
sion of Aneste
meral Hospital,
Jon Control, Deares
Number: 10062410