CERAMAGE

K050401 · Shofu Dental Corp. · EBF · Apr 28, 2005 · Dental

Device Facts

• Record ID: K050401
• Device Name: CERAMAGE
• Applicant: Shofu Dental Corp.
• Product Code: EBF · Dental
• Decision Date: Apr 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ceramage is light-curing polymer based crown and bridge, inlay, onlay composite resin materials for anterior and posterior. CERAMAGE is intended for use for following: - Used for crown restorations, e.g. jacket crowns and facing crowns for anterior and posterior, inlays, onlays, laminate veneers and upper structure of implants. - Used for extra/intra-oral repair of crown restorations and defect prosthetic restorations.

Device Story

Ceramage is a light-curing, polymer-based composite resin material used by dental professionals for restorative dentistry. It serves as a material for fabricating crowns, bridges, inlays, onlays, laminate veneers, and implant superstructures. It is also utilized for the repair of existing crown and prosthetic restorations. The material is applied by the clinician and cured using a light source to achieve the final hardened state. It provides a restorative solution for patients requiring tooth structure replacement or repair, functioning as a direct or indirect dental material.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-curing polymer-based composite resin. Formulated for anterior and posterior dental applications including crowns, bridges, inlays, onlays, and veneers. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for anterior and posterior crown restorations (jacket/facing), inlays, onlays, laminate veneers, implant upper structures, and extra/intra-oral repair of crown and prosthetic restorations.

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

APR 2 8 2005

Mr. David P. Morais Operations Manager ShoFu Dental Corporation 1225 Stone Drive San Marcos, California 92069-4059

Re: K050401

Trade/Device Name: Ceramage Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 1, 2005 Received: February 17, 2005

Dear Mr. Morais:

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 approvisions 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 (1 wr 1), it a 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. Morais

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 moun that 1 Dr mas mas statutes and regulations administered by other Federal agencies. or the Act of ally I outsal the Act's requirements, including, but not limited to: registration 1 ou muse compry William (21 CFR Part 801); good manufacturing practice and noung (= = = = forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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), 11 you don't 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 maj count 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,

Suette y. M. Michae. M.D.

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): 〈〈○5040]

Device Name: Ceramage

Indications For Use:

Ceramage is light-curing polymer based crown and bridge, inlay, onlay composite resin materials for anterior and posterior.

CERAMAGE is intended for use for following:

- Used for crown restorations, e.g. jacket crowns and facing crowns for anterior and . Osed for Crown restorations, org. Jacksons and upper structure of implants.
ﻢ

- posterior, inlays, onlays, laminate vehove and apple
Used for extra/intra-oral repair of crown restorations and defect prosthetic . restorations.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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)

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| Division of Anesthesiology, General Hospital, Infection Control. Dental Devices |

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