OPTIBOND SOLO PLUS 3

K011908 · Kerr Dental Materials Center · EBC · Sep 6, 2001 · Dental

Device Facts

• Record ID: K011908
• Device Name: OPTIBOND SOLO PLUS 3
• Applicant: Kerr Dental Materials Center
• Product Code: EBC · Dental
• Decision Date: Sep 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2

Intended Use

The intended use of OptiBond Solo Plus 3 is for bonding in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, bonding composite core build-up materials, pit and fissure sealant, and for indirect situations, i.e., veneers, onlays, inlays, crowns, post cementation.

Device Story

Multi-purpose dental bonding agent; used for direct and indirect restorative procedures. Applied by dental professionals in clinical settings to facilitate adhesion between tooth structure (enamel/dentin) and restorative materials (composites, porcelain, metal, amalgam). Functions as adhesive interface; improves retention and sealing of restorations. Applied directly to prepared tooth surfaces or restorative components; cured to form bond. Benefits include versatile clinical application across various restorative needs; provides reliable adhesion for both direct fillings and indirect prosthetic cementation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use similarities to the predicate device.

Technological Characteristics

Multi-purpose dental bonding agent. Chemical composition and specific material standards not detailed in provided text. Formulated for use as an adhesive for direct and indirect dental restorations. No electronic, software, or energy-based components.

Indications for Use

Indicated for dental bonding in direct procedures (composite to enamel/dentin, composite/porcelain repair, composite to metal, amalgam sealing, core build-ups, pit and fissure sealant) and indirect procedures (veneers, onlays, inlays, crowns, post cementation).

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Predicate Devices

• Guardian Seal (Kerr Corporation)

Submission Summary (Full Text)

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SEP = 6 2001

K011908

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

## Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: June 2001

### Device Name:

- Trade Name OptiBond Solo Plus 3 .
- Common Name Pit and Fissure Sealant ♥
- Classification Name Pit and Fissure Sealant and Conditioner, per 21 CFR § 872.3765 .

### Devices for Which Substantial Equivalence is Claimed:

- . Kerr Corporation, Guardian Seal
### Device Description:

The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials and fissure sealant, and for indirect situations including veneers, onlays, inlays, crowns, and post cementation.

### Intended Use of the Device:

The intended use of OptiBond Solo Plus 3 is for bonding in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, bonding composite core build-up materials, pit and fissure sealant, and for indirect situations, i.e., veneers, onlays, inlays, crowns, post cementation.

### Substantial Equivalence:

OptiBond Solo Plus 3 is substantially equivalent to other legally marketed devices in the United States. The sealant 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

Public Health Service

SEP - 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Colleen Boswell Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange. California 92867

Re: K011908

> Trade/Device Name: Optibond Solo Plus 3 Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant Regulatory Class: Class II Product Code: EBC Dated: June 14, 2001 Received: June 19, 2001

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.

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.

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# Page 2 - Ms. Boswell

This letter will allow you to begin marketing your device as described in your Section This icter will and w you to ocean including 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 If you desire specific ad 12002 for in vitro diagnostic devices), please contact the and additionally 21 CD [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). Other general information on your responsibilities under notheation (21 OF ICT I ar over 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,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section I

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Material Center

510(k) Number (if known):

Device Name: OptiBond Solo Plus 3

Indications For Use:

OptiBond Solo Plus 3 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, composite to metal, i.v., composite to banding composite core build-up materials, pit and fissure sealant, and indirect situations, i.e., veneers, onlays, inlays, crowns, (used in conjunction with a resin luting agent) post cementation.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, (Per 21 CFR 801.109) and General Hospital Devices (Optional Format 1-2-96) 510(k) Number