FUSION RESIN CEMENT AND CORE KIT

K070702 · Denali Corporation · EBF · May 10, 2007 · Dental

Device Facts

• Record ID: K070702
• Device Name: FUSION RESIN CEMENT AND CORE KIT
• Applicant: Denali Corporation
• Product Code: EBF · Dental
• Decision Date: May 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

Fusion Core is a high strength core material that offers the convenience of light curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resin/filler combination.

Device Story

Fusion Core is a light-cured, high-strength dental core build-up material. It is formulated as a hydrophilic resin/filler combination and is free of BIS-GMA. The material is designed to be applied by dental professionals in a clinical setting using either layering or core form techniques. It is intended to be cut and shaped by the clinician using standard dental burs, with the material properties allowing for cutting similar to natural dentin without clogging. The device benefits the patient by providing a stable foundation for dental restorations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, composition, and performance characteristics compared to predicate devices, supported by general usage history of similar dental restorative materials.

Technological Characteristics

High-strength, light-cured dental core material. Composition: hydrophilic resin/filler combination; BIS-GMA free. Form factor: restorative material for core build-up. Energy source: light-curing. No software or electronic components.

Indications for Use

Indicated for use as a dental core build-up material. Patient population not specified.

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.

Predicate Devices

• Clearfil Photo Core
• Kurarav SuperCure
• Centrix Rebilda LC
• Voco EnCore
• Centrix

Submission Summary (Full Text)

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Fusion Core Materials

## SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Dr. Jan G. Stannard 134 Old Washington Street Hanover, MA 02339-1629

Telephone [phone] Fax [phone] [e-mail]

DEVICE

Trade Name: Fusion Core Material Classification Name: Cement, Dental FDA Product Code: 872.3275

PREDICATE DEVICES: Clearfil Photo Core, Kurarav SuperCure, Centrix

Rebilda LC #. Voco EnCore, Centrix

MAY 1 0 2007

## DESCRIPTION AND INTENDED USE:

Fusion Core is a high strength core material that offers the convenience of fight curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resinffiller combination

## COMPARISON WITH PREDICATE PRODUCTS:

Fusion Core Material is substantially equivalent in design, composition and intended use to the products listed above.

#### SAFETY AND EFFECTIVENESS:

The Fusion Core Material is substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate kit products listed above.

The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR EBC 872.3765.

According to the NH Technology Assessment conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 30 years indicates a high benetif-to-risk ratio ... both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Jan G. Stannard President Denali Corporation 134 Old Washington Street Hanover, Massachusetts 02339-1629

MAY 1 0 2007

Re: K070702

Trade/Device Name: Fusion Core Material Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 23, 2007 Received: April 25, 2007

Dear Dr. Stannard:

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 Eederal Register.

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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" (21 CFR 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,

Susan Gunner

& 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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Fusion Core Material

# INDICATIONS FOR USE STATEMENT

1-070702 510 (k) Number (if known)

Device Name

# Fusion Core Material

#### Indications for Use:

Fusion Core is a high strength core material that offers the convenience of light curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resin/filler combination.

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

a J. Andementology Coneral Hospical, on Control, Demail Devices

Number KG 7022

**Prescription Use**
(Per 21 CFR 801.109) √

or

Over-The-Counter Use