Optibond Solo Plus 4 is a self-etch primer designed to work in conjunction with a tooth bonding agent. Optibond Solo Plus 4 can be used for indirect situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, post and core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns and bridges (used in conjunction with a resin luting agent).

Device Description

OptiBond Solo Plus 4 self-etch primer is designed for use with OptiBond Solo Plus adhesive (in Unidose or bottle delivery), both a Class II device which were granted marketing clearance by FDA following the submission of a 510(k) premarket notification. When used with OptiBond Solo Plus or OptiBond Solo Plus with Activator, the self etch primer can be used in the bonding of both direct and indirect restorations. The self-etch primer is used to eliminate the phosphoric acid etch step in the bonding process. Some advantages of using a self etch primer include reduction of post-operative sensitivity and an elimination of steps in the bonding process.

AI/ML Overview

This document is a 510(k) summary for a dental adhesive product, Optibond Solo Plus 4. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study demonstrating acceptance criteria for its performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be fully provided from the given text. The document does not describe specific performance acceptance criteria for the bonding agent, nor does it detail a study designed to test against such criteria.

Here's what can be inferred or stated based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document. The document's purpose is to demonstrate substantial equivalence, not to define or meet specific performance criteria beyond what is implied by the predicate device's performance.
Reported Device Performance: Not detailed in terms of specific quantitative outcomes of a performance study. The document broadly states that the device "functions in a manner similar" to predicate devices, implying comparable performance without providing the metrics.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not mentioned. No specific "test set" in the context of a performance study is described.
Data Provenance: Not mentioned. No performance data from clinical or laboratory studies is presented in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: Not applicable. Given there's no performance study data presented, there's no mention of experts establishing ground truth for such a study.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No test set or ground truth establishment process is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No. This type of study (common in imaging AI) is not relevant to a dental bonding agent and is not mentioned or implied in the document.
Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

Standalone Study: No. This concept is not applicable to a physical dental bonding agent product.

7. Type of Ground Truth Used:

Type of Ground Truth: Not applicable. As no performance study with ground truth is described, this information is not available.

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm or a "training set."

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does provide:

Device Name: Optibond Solo Plus 4
Intended Use: Direct situations (composite to enamel/dentin, repair, amalgam sealing, post and core build-up) and indirect situations (veneers, onlays, inlays, crowns, bridges with resin luting agent).
Predicate Devices: Kuraray America, Inc., Clearfil Liner Bond 2V.
Claim of Substantial Equivalence: The document asserts that Optibond Solo Plus 4 is substantially equivalent to other legally marketed devices, including the predicate, and "functions in a manner similar to" these. This is the primary "proof" offered for regulatory clearance, not a detailed performance study against specific criteria.

Summary

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BRON DENTAL SPECIALTIES

FEB 2 2 2002

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

December 2001

Date Summary Prepared:

Device Name:

Trade Name -- Optibond Solo Plus 4 .
Common Name Resin Tooth Bonding Agent •
Common Name -- Resin Tooth Bonding Agent, per 21 CFR § 872.3200 .

Devices for Which Substantial Equivalence is Claimed:

Kuraray America, Inc., Clearfil Liner Bond 2V .

Device Description:

OptiBond Solo Plus 4 self-etch primer is designed for use with OptiBond Solo Plus adhesive of OptiBond Solo Plus 4 seti-etch primer is designior (in Unidose or bottle delivery), both a Class II
OptiBond Solo Plus adhesive with dual cure activator (in cubmission of a 5 OptiBond Solo Flus addiesIve will dadi care access by FDA following the submission of a 510(k)
device which were granted marketing clearance by Flaxed Solo Rus with Acity device which were grained marketing trearance of the or OptiBond Solo Plus will Activator,
premarket notification. When used with OptiBond Solo Plus or restorations. The self premarket notification. When used in the bonding of both direct restorations. The self-etch the self etch primer can be used in the bonumy of the bonding process. Some advantages
primer is used to eliminate the phosphoric acid etch separitive and an elimination of primer is used to enminate the phospilore actires and other of i
of using a self etch primer include reduction of post-operative sensitivity and an elimination of steps in the bonding process.

Intended Use of the Device:

The intended use of Optibond Solo Plus 4 can be used for direct situations, i.e., composite to enamel The intended tise of Optional Solo I rus 4 can or assess to metal, annalgam sealing, post and bridges and/or dentin, composite repart, porcelan ropan, composite of theys, crowns and bridges
core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crown (used in conjunction with a resin luting agent).

Substantial Equivalence:

Optibond Solo Plus 4 is substantially equivalent to other legally marketed devices in the United Optibond Solo Plus 4 is substantially equivalent volter regal, Inc. finctions in a maners similar to
States. The self-etching primer marketed by Kurray Marchal Materials Cen States. The self-etching primer marketed by Kultiray Princitus, and

800-537-7824 714-516-7400 1717 West Collins Avenue, Orange, CA 92800

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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the Department of Health & Human Services, which is an abstract image of an eagle. The text around the seal reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

Ms. Colleen Boswell Kerr Dental Materials Center Center A Division of Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K014027

Trade/Device Name: Optibond Solo Plus 4 Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: December 4, 2001 Received: December 6, 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 approvisions of the Act. The general controls provisions of the Act include contrements 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 (1 will), it ind) 00 basyon 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 I ou must compry with an are reseling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pac 007), lacems (QS) regulation (21 CFR Part 820); and if requirences as set forth in als quality sion 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 I mis letter will anow you to ocelli manage you of substantial equivalence of your device to 310(K) promation nownloate 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 II you desire specific ac not 10-10-10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Othoo of Collightance are, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nothication (21CF ICPart For 001997).
the Act may be obtained from the Division of Small Manufacturers, International and the Act may be counter 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

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):	2014027

Device Name: Optibond Solo Plus 4

Indications For Use:

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

Labels	Values
510(k) Number	K014007

(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.