FORMCORE DC, MODEL 28-700100

K061664 · J. Morita USA, Inc. · EBF · Sep 8, 2006 · Dental

Device Facts

• Record ID: K061664
• Device Name: FORMCORE DC, MODEL 28-700100
• Applicant: J. Morita USA, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FormCore DC is a dual cure dental material intended to be used for core build up.

Device Story

FormCore DC is a dual-cure dental material used by dentists for core build-up procedures. The material is applied to the tooth structure to provide a foundation for subsequent crown or bridge restorations. It functions as a restorative dental material, hardening through a dual-cure mechanism (light-cure and chemical-cure). The device is used in a clinical dental setting by licensed practitioners. It benefits patients by restoring tooth structure, enabling the placement of final prosthetic restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cure dental resin material; tooth-colored; indicated for core build-up; classified as Class II under 21 CFR 872.3690 (Product Code EBF).

Indications for Use

Indicated for core build-up procedures in dental patients requiring restorative treatment. Prescription use only.

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

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2006

Mr. Takeshi Inouc Product Development J. Morita USA, Incorporated 9 Mason Irvine, California 92618

Re: K061664

Trade/Device Name: FormCore DC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 12, 2006 Received: June 14, 2006

Dear Mr. Inoue:

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. Inoue

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,

Clare

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 Statement

510(k) Number (if known): Not Assigned to date_______________________________________________________________________________________________________________________________

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Device Name:

FormCore DC

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Indications For Use:

..

FormCore DC is a dual cure dental material intended to be used for core build up.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">✓</span> |
|----------------------|----------------------------------------------------------------------------|
| | OR (Per 21 CFR 801.109) |
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| Member: | <span style="text-decoration: overline;">k661664</span> |