OptiBond Solo Plus is a multi-purpose bonding agent designed to be used in direct Situations, I.C., composite to enailer and/or dentin, composite repair, porcelain repair, composite to mount, analgain commons, inlays, crowns, Maryland bridges, post cementation.

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, porcelain repair, composite to metal, amalgam bonding and bonding composite core build-up materials. Additionally, because the device contains a dual cure catalyst, OptiBond Solo Plus can be used for indirect situations as well including veneers, onlays, inlays, crowns, Maryland bridges and post cementation.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for a dental bonding agent called "OptiBond Solo Plus." This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish acceptance criteria and prove device performance through a detailed study comparing the device against those criteria.

Therefore, the document does not contain the information requested regarding:

A table of acceptance criteria and reported device performance.
Sample sizes used for test and training sets, or data provenance.
Number and qualifications of experts for ground truth.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study details.
Standalone performance information.
Specific details on how ground truth was established for testing or training sets.

The document primarily focuses on:

Device Name: OptiBond Solo Plus
Intended Use: Bonding in direct situations (composite to enamel/dentin, composite repair, porcelain repair, composite to metal, amalgam bonding, core build-up materials) and indirect situations (veneers, onlays, inlays, crowns, Maryland bridges, post cementation).
Predicate Device: Dentsply International, Prime & Bond 2.1
Claim of Substantial Equivalence: The device functions in a similar manner and is intended for the same use as the predicate device.

To obtain the requested information, one would typically need access to the full 510(k) submission, including any performance studies or validation reports, which are not present in this summary.

Summary

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Image /page/0/Picture/0 description: The image contains the logo for Sybron Dental Specialties, along with the text "Section III - 510(k) Summary of Safety and Effectiveness". There is also a handwritten number "199" in the top left corner and "K990498" on the right side of the logo. The logo features the letters "sds" in a stylized font.

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared:

February 1999

Device Name:

Trade Name OptiBond Solo Plus ●
Common Name Bonding Agent ●
Classification Name Resin Tooth Bonding Agent, per 21 CFR § 872.3200 .

Devices for Which Substantial Equivalence is Claimed:

. Dentsply International, Prime & Bond 2.1

Device Description:

Intended Use of the Device:

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

Substantial Equivalence:

OptiBond Solo Plus is substantially equivalent to other legally marketed devices in the United States. The bonding agent marketed by Dentsply International 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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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 1999

Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

K990498 Re : Optibond Solo Plus Trade Name: Regulatory Class: II Product Code: KLE February 16, 1999 Dated: Received: February 17, 1999

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate abe Beated in the enough 3, 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Boswell

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets probles, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note che Office or Compiland, "Misbranding by reference to the regulation entification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information of your be Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

510(k) Number:

K990498

Device Name: OptiBond Solo Plus

Indications for Use:

OptiBond Solo Plus is a multi-purpose bonding agent designed to be used in direct Optibolia Solo Frus is a manel and/or dentin, composite repair, porcelain repair, Situations, I.C., composite to enailer ag, bonding composite core build-up materials, and composite to mount, analgain commons, inlays, crowns, Maryland bridges, post cementation.

●

Susan Roaser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 1299 098 510(k) Number.

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
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.(b)
Classification. Class II.