OptiBond 2 is a multi-purpose bonding agent designed to be used 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, cavity liner, pulp capper, pit and fissure sealant, and indirect situations, i.e., onlays, inlays and crowns.

Device Description

AI/ML Overview

This document (K012322) is a 510(k) premarket notification for a dental bonding agent named OptiBond 2. It does not contain any information regarding acceptance criteria, performance studies, or clinical trial data. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

The document primarily focuses on:

Device Name: OptiBond 2
Common Name: Pit and Fissure Sealant
Classification Name: Pit and Fissure Sealant and Conditioner
Substantial Equivalence: Claimed to be substantially equivalent to Kerr Corporation's Guardian Seal.
Device Description: A multi-purpose bonding agent for various direct and indirect dental applications.
Intended Use: Details the specific dental procedures where OptiBond 2 is intended to be used.
FDA Clearance: A letter from the FDA stating that the device has been reviewed and can be marketed based on its substantial equivalence to legally marketed predicate devices.

The document is purely administrative and regulatory in nature, indicating FDA clearance, but it does not include the technical or clinical data that would typically define and demonstrate meeting acceptance criteria.

Summary

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KO12322

AUG 3 0 2001

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) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: July 2001

Device Name:

Trade Name OptiBond 2 .
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:

Intended Use of the Device:

The intended use of OptiBond 2 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, cavity liner, pulp capper, pit and fissure sealant, and indirect situations, i.e., onlays, inlays and crowns.

Substantial Equivalence:

OptiBond 2 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.

1717 West Collins Avenue, Orange, CA 92887 800-537-7824 714-516-7400

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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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2001

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

Re: K012322 Trade/Device Name: OptiBond 2 872.3200 Requlation Number: II Regulatory Class: Product Code: KLE Dated: July 18, 2001 Received: July 23, 2001

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to we have reviewed your booced above and we have determined the market the device references above (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the cholobals, commerce prior to May 28, 1976, devices markedda in a the Medical Device Amendments, or to the chacement aus been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions or cho, 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 (Premarket Approval), it may (Special Controls additional controls. Existing major be subject to back adable can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ rederar hegulation determination assumes compliance with Bubbeancially ogamanufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 - Ms. Boswell

concerning your device in the Federal Register. Please note: concerning your devros remarket notification submission does chis response to your pro you might have under sections 531 not arrect any origated for devices under the Electronic chrough Jr. Or on notrol provisions, or other Federal laws or requlations.

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 marketed predicate woits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulacion (ir (i' devices) , please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Optarnotional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO12322

Section I

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Material Center

510(k) Number (if known): KO12322

Device Name: OptiBond 2

Indications For Use:

OptiBond 2 is a multi-purpose bonding agent designed to be used 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, cavity liner, pulp capper, pit and
fissure sealant, and indirect situations, i.e., onlays, inlays and crowns.

(Division Sign-Off) Pamela Scott for Susan Runner
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number KO12322

Labels	Values
Prescription Use(Per 21 CFR 801.109)	✓
Over-the-Counter Use

(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)

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.