OptiBond Solo Plus Activator is a multi-purpose bonding agent designed to work in conjunction with a tooth bonding agent. OptiBond Solo Plus Activator can be used for the bonding of core materials, resin cements, and cementation of posts and amalgams.

Device Description

OptiBoud Solo Plus Activator is a multi-purpose bonding agent designed to work in conjunction with Optitloud Solo Phus, a Class II device which was granted marketing clearance by FDA following the submission of a 510(k) premarket notification. OptiBond Solo Plus Activator can be used for the bonding of core materials, resin cements, and comentation of posts and amalgams.

AI/ML Overview

The provided text is a 510(k) summary for the OptiBond Solo Plus Activator, a dental resin bonding agent. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance criteria through a detailed clinical study in the way a new medical device would.

Therefore, many of the requested categories related to clinical study design, ground truth, and expert evaluation are not applicable to this document. The focus of this 510(k) is on demonstrating similarities in function and intended use to an already marketed device, not on proving de novo clinical effectiveness.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Device Performance (OptiBond Solo Plus Activator)
Functional similarity to predicate device (Dentsply Caulk, Prime & Bond NT Dual Cure)	Functions in a manner similar to Prime & Bond NT Dual Cure.
Intended Use: Bonding of core materials, resin cements, and cementation of posts and amalgams.	Has the same intended use as Prime & Bond NT Dual Cure.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The document states that a table comparing bonding properties is included, but the table itself (with specific data and sample sizes) is not present in the provided text. This is a substantial equivalence claim, so the "test set" in the context of a clinical trial for performance is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. This information pertains to a clinical efficacy or performance study, which is not the primary subject of a 510(k) summary for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. As above, this relates to clinical study design, which isn't detailed in this 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental bonding agent, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As above, this relates to AI/software performance, not a dental material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided. The "ground truth" for a chemical bonding agent would typically be measured through laboratory tests (e.g., bond strength, shear strength) or potentially clinical outcomes, but the specific methodologies and their "ground truth" establishment are not detailed in this 510(k) summary. The document mentions a comparison of "bonding property," suggesting laboratory-based performance metrics rather than expert consensus on clinical outcomes.

8. The sample size for the training set

Not applicable / Not provided. This concept (training set) applies to machine learning models, not to a chemical dental product.

9. How the ground truth for the training set was established

Not applicable / Not provided. This concept (training set ground truth) applies to machine learning models, not to a chemical dental product.

Summary of Study (Based on 510(k) Content):

The provided text indicates that Sybron Dental Specialties, Inc. submitted a 510(k) premarket notification (K012082) for their device, OptiBond Solo Plus Activator. The "study" mentioned is a substantial equivalence comparison to a legally marketed predicate device, Dentsply Caulk's Prime & Bond NT Dual Cure (510(k) K982394).

The basis for substantial equivalence is that OptiBond Solo Plus Activator:

Functions in a manner similar to the predicate device.
Is intended for the same use: bonding of core materials, resin cements, and cementation of posts and amalgams.

The document states: "The table on the following page compares the bonding property of OptiBond Solo Plus Activator to one other legally marketed...device." This implies that laboratory testing of a "bonding property" was conducted and compared to the predicate device's performance. However, the details of this specific testing (e.g., specific bond strength values, sample sizes for that comparison, methodology) are not included in the provided text.

The FDA's letter (Page 2) confirms that they reviewed the 510(k) and determined the device to be substantially equivalent based on the information provided by the submitter.

Summary

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SEP 2 0 2001

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white.

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 Collecn Boswell - Contact Person

Date Summary Prepared: June 2001

Device Name:

Trade Name -- OptiBond Solo Plus Activator ﻮ
Common Name -- Resin Tooth Bonding Agent *
- Classification Name - Resin Tooth Bonding Agent, per 21 CFR § 872.3200

Devices for Which Substantial Equivalence is Claimed:

Dentsply Canlk, Prime & Bond NT Dual Cure .

Device Description:

Intended Use of the Device:

The intended use of OptiBond Solo Plus Activator is for bonding of core materials, resin coments, and cementation of posts and amalgams.

Substantial Equivalence:

OptiBond Solo Plus Activator is substantially equivalent to other legally marketed devices in the United States. The bonding agent marketed by Dentsply Caulk functions in a manner sincilar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.

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Section IV -- Substantial Equivalence

The table on the following page compares the bonding property of OptiBond Solo Plus Activator to one other legally marketed, Class II device which was granted marketing clearance by FDA following the submission of a 510(k) premarket notification. The 510(k) number for the predicate device, Prime & Bond NT Dual Cure, is K982394 dated September 21,1998.

Representative labeling for the device to which equivalonce is being claimed is also included on the following pages. OptiBond Solo Plus Activator functions in a manner similar to and is intended for the same use as Prime & Bond NT Dual Cure marketed by Dentsply Caulk. Additionally, the product specifications for OptiBond Solo Plus Activator are also provided in this section.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

SEP 2 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K012082

Trade/Device Name: Optibond Solo Plus Activator Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 29, 2001 Received: July 3, 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.

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Page 2 - Ms. Boswell

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 (section 531-542 of the Act; 21); CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the 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, International 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. Uhlmann

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

Labels	Values
510(k) Number (if known):	K012082

Device Name: OptiBond Solo Plus Activator

Indications For Use:

Susan Runner

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

Labels	Values
510(k) Number	K012082

(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.