CLEAFIL DC CORE AUTOMIX

K043177 · Kuraray Medical, Inc. · EBF · Dec 17, 2004 · Dental

Device Facts

• Record ID: K043177
• Device Name: CLEAFIL DC CORE AUTOMIX
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CLEARFIL DC CORE AUTOMIX is indicated for the following application 1) Core build up of vital or non-vital tooth

Device Story

CLEARFIL DC CORE AUTOMIX is a dental material used for core build-up procedures on vital or non-vital teeth. It is a dual-cure (DC) resin-based material supplied in an automix delivery system. The device is intended for professional use by dentists in a clinical setting to restore tooth structure prior to crown placement. It functions as a restorative material to provide a stable foundation for prosthetic restorations.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Dual-cure resin material for tooth shade restoration. Classified under 21 CFR 872.3690 (Product Code EBF). Delivered via automix system.

Indications for Use

Indicated for core build-up of vital or non-vital teeth.

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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Kuraray Medical, Incorporated C/O Mr. Satoshi Yamaguchi Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022

Re: K043177

Trade/Device Names: CLEARFIL™ DC Core Automix Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 12, 2004 Received: November 22, 2004

Dear Mr. Yamaguchi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bootion 910(x) produce is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreative to regary inter of the Medical Device Amendments, or to devices that prof to May 26, 1770, the endentions aske the provisions of the Federal Food, Drug, and Cosmetic Ilave bech recidissimou in accerances nof a premarket approval application (PMA). You may, Act (Act) that ao not require approval othe general controls provisions of the Act. The general therefore, market the device, sabject to annual registration, listing of devices, good Controls provisions of the rise necessary misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be Illay be subject to such additions. 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. Satoshi Yamaguchi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DAY 3 issualite or our device complies with other requirements of the Act or mall Ford nas made a decemination administered by other Federal agencies. You must comply with ally rederal statutes and regulations abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, moracturing practice requirements as set forth in the quality labemig (21 CFR Part 801), good fart 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) I mis letter wilf anow you've ough mating of substantial equivalence of your device to a legally premaired noutied.com - The Plassification 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 if you desire of Compliance at [phone]. Also, please note the regulation entitled, Colifical in Other of Compilance matification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrth/dsma/dsmamain.html

Sincerely yours,

Chiu S. Liu, Ph.D.

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

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510(k) Number (if known): K04 3177

Device Name: CLEARFIL DC CORE AUTOMIX

Indications for Use

CLEARFIL DC CORE AUTOMIX is indicated for the following application 1) Core build up of vital or non-vital tooth

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

Susan Rinner

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices Concurrelide be on Dien,

Prescription Use

OR

Over-The-Counter Use

(Optional Format 1-2-96)