EPRICORD

K033267 · Kuraray Medical, Inc. · EBF · Dec 22, 2003 · Dental

Device Facts

• Record ID: K033267
• Device Name: EPRICORD
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Dec 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Epricord is indicated for the following applications: - 1) Restorations using facing crowns, facing bridges, or jacket crowns. - 1) Repairs of the polymer crown and bridge material or porcelain of facing crowns and jacket crowns.

Device Story

Epricord is a tooth shade resin material used in dental restorative procedures. It is applied by dental professionals in a clinical setting to create or repair facing crowns, bridges, and jacket crowns. The material functions as a restorative agent to restore tooth form and function. It is used by dentists to improve patient dental aesthetics and structural integrity of damaged teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tooth shade resin material; Class II device; regulated under 21 CFR 872.3690.

Indications for Use

Indicated for dental patients requiring restorations (facing crowns, bridges, jacket crowns) or repairs of existing polymer crown/bridge material or porcelain facings.

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.

Submission Summary (Full Text)

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DEC 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical, Incorporated C/O Ms. Satoshi Yamaguchi Kuraray America, Incorporated 101 East 25 Street, 26th Floor New York, 10022

Re: K033267

Trade/Device Name: Epricord Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin material Regulatory Class: II Product Code: EBF Dated: October 6, 2003 Received: October 22, 2003

Dear Ms. Yamaguchi

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. Lehn

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 iabeling 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/dsma/dsmamain.html

Sincerely vours,

CluLs

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):K033267

Device Name: Epricord

Indications For Use:

Epricord is indicated for the following applications:

- 1) Restorations using facing crowns, facing bridges, or jacket crowns.
- 1) Repairs of the polymer crown and bridge material or porcelain of facing crowns and jacket crowns.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Runor

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:***_***_

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