PRELUDE ONE

K090106 · Danville Materials, Inc. · KLE · Mar 31, 2009 · Dental

Device Facts

• Record ID: K090106
• Device Name: PRELUDE ONE
• Applicant: Danville Materials, Inc.
• Product Code: KLE · Dental
• Decision Date: Mar 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prelude One is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges.

Device Story

Prelude One is a light-cured dental adhesive used by dentists in clinical settings. It functions as a bonding agent to facilitate the adhesion of restorative materials (composites, compomers) to tooth structure (enamel/dentin) or to repair existing restorations (porcelain/composite). The clinician applies the adhesive to the prepared tooth surface or restoration, followed by light curing to polymerize the material. This process creates a bond that secures the restorative material, aiding in the structural repair and functional restoration of teeth. It is intended for professional use in dental offices.

Technological Characteristics

Light-cured resin-based dental adhesive. Formulated for bonding composites and compomers to tooth structure and restorative materials. Class II medical device.

Indications for Use

Indicated for dental patients requiring direct restorations (composites/compomers to enamel/dentin), composite or porcelain repairs, post and core build-up, and indirect restorations (veneers, onlays, inlays, crowns, bridges).

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• Clearfil S³
• Xeno IV

Submission Summary (Full Text)

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K090106

MAR 3 1 2009

## 510(k) Summary of Safety and Effectiveness

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(As Required by 21 C.F.R. §807.92)

| Applicant: | Danville Materials, Inc.<br>2021 Omega Dr.<br>San Ramon, CA 9458 | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Criag R. Bruns<br>Phone [phone]<br>Fax [phone]<br>e-mail: [e-mail] | |
| Date of Summary: | | |
| Device Name: | Prelude One | |
| Common Name: | Agent, Tooth Bonding, Resin | |
| Classification Names: | Regulation Number | Product code |
| | 21 CFR 872.3200 | KLE |
| Device Description: | Prelude One is a dental bonding agent used to restore all classes of cavities | |
| Predicate Device: | The device is substantially equivalent to other legally marketed devices in the<br>United States including Clearfil S³ and Xeno IV. | |
| Intended Use: | Prelude One is a light cured adhesive designed for direct restorations, i.e.<br>composites and compomers to enamel and/or dentin, composite repairs,<br>porcelain repairs and post and core build-up materials, and indirect restorations<br>such as veneers, onlays, inlays, crowns and bridges. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with three stripes extending from its body, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 3 1 2009

Ms. Lindsay Tilton Document Control/Marketing Associate Danville Materials, Incorporated 3420 Fostoria Way, Suite A-200 San Ramon, California 94583

K090106 Re:

> Trade/Device Name: Prelude One Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 12, 2008 Received: January 1, 2009

Dear Ms. Tilton:

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 -- Ms. Tilton

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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Suite Y. Michaud Omd.

Ginette Y. Michaud, M.D. Acting 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: Pending K090106

Prelude Device Name: __

Indications For Use:

Prelude One is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges.

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-CONTIUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pearson

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

510(k) Number: K090106