OPTIBOND FL

K031444 · Kerr Dental Materials Center · KLE · Jul 2, 2003 · Dental

Device Facts

• Record ID: K031444
• Device Name: OPTIBOND FL
• Applicant: Kerr Dental Materials Center
• Product Code: KLE · Dental
• Decision Date: Jul 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of OptiBond FL is for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and for bonding veneers, onlays, and inlays.

Device Story

OptiBond FL is a multi-purpose resin bonding agent used by dental professionals in clinical settings. It facilitates the adhesion of composite restorative materials to tooth structures (enamel and dentin) and various dental substrates including metal and porcelain. The agent is applied during restorative procedures such as composite repairs, core build-ups, and the placement of veneers, onlays, and inlays. By creating a chemical bond between the restorative material and the tooth or prosthetic surface, the device improves the retention and marginal integrity of dental restorations, potentially increasing the longevity of the treatment and reducing the risk of secondary decay or restoration failure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison to the predicate device.

Technological Characteristics

Resin-based dental bonding agent. Multi-purpose formulation designed for adhesion to enamel, dentin, metal, and porcelain. Classified as a Class II medical device under 21 CFR 872.3200.

Indications for Use

Indicated for dental restorative procedures requiring bonding of composite materials to enamel, dentin, metal, or porcelain surfaces, including composite repairs, core build-ups, and cementation of veneers, onlays, and inlays.

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 2 (Kerr Corporation)

Submission Summary (Full Text)

{0}------------------------------------------------

JUL 2 2003

sds

SYBRON DENTAL SPECIALTIES

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-74 84 - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: May 2003

# Device Name:

- Trade Name OptiBond FL .
- . Common Name - Resin Tooth Bonding Agent
- Classification Name Resin Tooth Bonding Agent, per 21 CFR § 872.3200 .

### Devices for Which Substantial Equivalence is Claimed:

- Kerr Corporation, OptiBond Solo Plus 2 .
### Device Description:

The device is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.

### Intended Use of the Device:

The intended use of OptiBond FL is for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and for bonding veneers, onlays, and inlays.

### Substantial Equivalence:

OptiBond FL is substantially equivalent to other legally marketed devices in the United States. The bonding agent marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2003 JUL

2003

Kerr Dental Materials Center C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

Re: K031444

Trade/Device Name: Optibond™ FL Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: May 05, 2003 Received: May 08, 2003

Dear Ms. Boswell:

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.

{2}------------------------------------------------

Page 2 - Ms. Colleen Boswell

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours

Susan Runne

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

# Section I - Indications for Use

Ver/ 3 - 4/24/96 Applicant: Kerr Dental Material Center 510(k) Number (if known): Device Name: OptiBond FL Indications For Use: OptiBond FL is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays. Division of Anesthesiology, General Ho ction Control. Dental De (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)