PRELUDE

K040952 · Danville Materials, Inc. · KLE · Jun 29, 2004 · Dental

Device Facts

• Record ID: K040952
• Device Name: PRELUDE
• Applicant: Danville Materials, Inc.
• Product Code: KLE · Dental
• Decision Date: Jun 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prelude 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. When used with Prelude Activator, Prelude may also be used with self or dual cure materials.

Device Story

Prelude is a light-cured dental adhesive system; used by dentists in clinical settings for bonding restorative materials to tooth structure. Input: dental restorative materials (composites, compomers) and tooth surfaces (enamel, dentin). Operation: applied to prepared tooth surfaces; light-cured to create adhesive bond. When combined with Prelude Activator, supports self-cure or dual-cure restorative materials. Output: bonded restoration. Benefit: facilitates secure attachment of direct and indirect dental restorations.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Light-cured resin-based dental adhesive. System includes bonding agent and optional activator for self/dual-cure compatibility. Formulated for application to enamel and dentin. Class II medical device.

Indications for Use

Indicated for dental patients requiring direct restorations (composites/compomers to enamel/dentin), composite repairs, 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

• Optibond Solo Plus (K990498)
• Optibond Solo Plus (K014027)
• Clearfil SE (K990040)
• Optibond Solo Plus Activator (K012082)

Submission Summary (Full Text)

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## K040952

JUN 2 9 2004

## 510(k) Summary of Safety and Effectiveness (As Required by 21 C.F.R. §807.92)

| Applicant: | Danville Materials, Inc.<br>2021 Omega Dr.<br>San Ramon, CA 94583 |
|----------------------|----------------------------------------------------------------------------|
| Contact Person: | Craig R. Bruns |
| | Phone [phone] |
| | Fax [phone] |
| e-mail: | [e-mail] |
| Date of summary | March 12, 2004 |
| Device name | Prelude |
| Common name | Agent, Tooth Bonding, Resin |
| Classification names | Regulation Number<br>21 CFR 872.3200<br>Product Code<br>KLE |
| Device Description | Prelude 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 United States including Optibond Solo Plus and Optibond Solo Plus 4 (K990498 & K014027), Clearfil SE (K990040) and Optibond Solo Plus Activator (K012082).

Intended Use Prelude 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. When used with Prelude Activator, Prelude may also be used with self or dual cure materials.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three parallel lines that curve and flow downwards.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2004

Mr. Craig R. Bruns President Danville Materials, Inc. 2021 Omega Road San Ramon, California 94583-1229

Re: K040952

Trade/Device Name: Prelude Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 23, 2004 Received: June 24, 2004

Dear Mr. Bruns:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your over of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the encreated to the Medical Device Amendments, or to devices that prov to way 20, 1970, and cordance 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 thereone, mancer me act include requirements for annual registration, listing of devices, good connologic provisions or abeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your device to such additional controls. Existing major regulations affecting your device can be finay of subject to sten adam 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. Craig R. Bruns

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession in other requirements of the Act of that FDA nas made a delectimization that your cell be other Federal agencies. You must comply with CEP Bett 807V any Federal statures and regulations administered of to: registration and listing (21 CFR Part 807); all the Act s requirements, including, but not interest see requirements as set forth in the quality labeling (21 CFR 1 art 001), good management of applicable, the electronic product radiation systems (QB) rogalazen ons 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 his letter whi anow you to ought manteeing your and equivalence of your device to a legally premarket notification. The PDA midning of bassification 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 specific ativice for your actives at [phone]. Additionally, for questions on the promotion comact the Office of Compliance at [phone] contact the Office of Compliance at [phone] (2) OFF and advertising of your device, prease verrance to premarket notification" (21CFF)
please note the regulation entitled, "Misbranding by reference to premarket notification th please note the regulation entities, "Information on your responsibilities under the Act may Patt 807.97) you they obtain. Other generaliantacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clive S. Lewis, 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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## Indications for Use

K040452 510(k) Number (if known): Pending

Device Name: Prelude

Indications For Use:

Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or I reado is a right direct can repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges. When used with Prelude may also be used with self or dual cure materials.

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)

Suar Rann

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

510(k) Number: K041015