Direct bonding to dentin and/ or enamel .
Bonding composite to composite, porcelain and/ or metal .
. Opaquing metal (used in conjunction with an opaque resin stain or cement)
Bonding with dual cure and self cure composite resins, such as cements and core build up . materials
Amalgam sealing
Dentin sealing ●

Indirect applications

Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, inlays, ● onlays and veneers (used in conjunction with resin luting agents)
Bonding of fiber and metal posts (in conjunction with resin luting agents) ●

Device Description

B1P Adhesive is a fifth generation dental bonding agent that is intended to be used for direct composite bonding and indirect restoration in combination with a dental restorative material. The formula is used based on a total etch technique and combines the primer and adhesive into one component. The application procedure requires steps of acid etching and rinsing, followed by the application of the B1P Adhesive. It is a light curable adhesive with the option of being dual cured when mixed with the dual cure activator.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the B1P Adhesive device:

The documentation for K111431, B1P Adhesive, does not explicitly define quantitative acceptance criteria in a table format as often seen in medical device submissions for diagnostic or AI-driven devices. Instead, the "acceptance criteria" are implied through the concept of "substantial equivalence" to predicate devices, supported by specific bench test results (bonding strengths) and biocompatibility.

The study presented is not a typical clinical study with a defined test set, ground truth experts, or complex statistical analysis for performance metrics akin to an AI device. It's a submission for a dental bonding agent, and the evaluation is primarily focused on demonstrating physical and chemical properties similar to existing, legally marketed devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantitative acceptance criteria in a table format are not present in the provided text. The overall "acceptance criterion" is achieving substantial equivalence to the predicate devices. The performance data is presented qualitatively and comparatively.

Acceptance Criterion (Implied)	Reported Device Performance (Comparative)
Biocompatibility	Meets ISO 10993 standards; safe for intended use.
Direct Bonding Strength	Evaluated through bench testing and demonstrated performance comparable to predicates. (Specific values not provided)
Indirect Bonding Strength	Evaluated through bench testing and demonstrated performance comparable to predicates. (Specific values not provided)
Functional Equivalence	Functions similarly to predicate devices (Dentin Conditioning and Adhesive (Bond 1), Optibond Solo Plus 2, lBond Total Etch) in application and intended use.
Technological Characteristics	Similar characteristics to predicates (e.g., acetone-based, single-coat application, ambient temperature storage, filler technology, glutaraldehyde as desensitizer).

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

Sample Size for Test Set: Not specified. The document refers to "bench testing used to evaluate the performance characteristics of B1P Adhesive compared to the predicate devices" for bonding strengths. Details on the number of samples or specimens tested are not provided.
Data Provenance: Not explicitly stated, but assumed to be from laboratory bench testing conducted by the manufacturer, Sybron Dental Specialties, Inc. (or affiliated labs). The data is retrospective in the sense that it's generated for this submission, not from a prospective clinical trial. Country of origin not mentioned but likely US-based given the submitter's location.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable/not provided in the context of this submission. The "ground truth" for bonding strengths would be derived directly from the physical measurements obtained during the bench tests, not from expert consensus or interpretation.

4. Adjudication Method for the Test Set

This is not applicable/not provided. There was no expert-based adjudication process for the bench tests described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable/not provided. The device is a dental bonding agent, not an AI-driven diagnostic or assistive technology. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or is relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable/not provided. The device is a physical product (a dental bonding agent), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation (bonding strengths) was based on direct laboratory measurements from bench testing. For biocompatibility, it was based on adherence to ISO 10993 standards. There was no pathology, expert consensus, or outcomes data used as ground truth in the way it might be for a diagnostic device.

8. The Sample Size for the Training Set

This is not applicable/not provided. There is no "training set" in the context of this device and its evaluation. The product's formulation and development would involve research and development, but this is not framed as a "training set" for an algorithm.

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

This is not applicable/not provided as there is no training set mentioned or implied. Product development for a chemical formulation relies on chemical principles, materials science, and iterative testing, not establishing ground truth for a training set in the AI sense.

Summary of Device Evaluation Approach:

The submission for B1P Adhesive relies on a predicate device comparison and bench testing to demonstrate substantial equivalence. The key evidence provided includes:

Biocompatibility: Conformance to ISO 10993 standards.
Technological Characteristics Comparison: Detailed descriptions of similarities and differences with three legally marketed predicate devices, highlighting how B1P Adhesive functions similarly for the same intended use.
Bench Testing Data: Evaluation of direct and indirect bonding strengths, confirming performance characteristics comparable to the predicate devices (though specific quantitative results are not included in the summary).

Crucially, the document explicitly states: "Clinical testing has not been conducted on this product." This means the demonstration of substantial equivalence is entirely based on non-clinical data and comparison to existing products.

Summary

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K111431

AUG - 1 2011

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

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: May 2011

Device Name:

. Trade Name - B1P Adhesive
. Common Name – Bonding Agent
. Classification Name - Resin Tooth Bonding Agent, per 21 CFR § 872.3200
. Product Code: KLE

Devices for Which Substantial Equivalence is Claimed:

. Pentron Clinical, Dentin Conditioning and Adhesive (Bond 1), K973388
. Kerr Corporation, Optibond Solo Plus 2, K991808
Heraeus Kulzer GmbH, IBond Total Etch, K083652

Device Description:

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Intended Use of the Device:

B1P Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following:

Direct Applications

Direct bonding to dentin and/ or enamel .
Bonding composite to composite, porcelain and/ or metal Opaquing metal (used . in conjunction with an opaque resin stain or cement)
Bonding with dual cure and self cure composite resins, such as cements and core . build up materials
Amalgam sealing .
Dentin sealing .

Indirect applications

Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, . inlays, onlays and veneers (used in conjunction with resin luting agents)
Bonding of fiber and metal posts (in conjunction with resin luting agents) .

Summary of Technological Characteristics:

B1P Adhesive is substantially equivalent to three other legally marketed devices in the United States: Dentin Conditioning and Adhesive (Bond 1), Optibond Solo Plus 2 and lBond Total Etch.

B1P Adhesive functions in a manner similar to and is intended for the same use as Dentin Conditioning and Adhesive (Bond 1) that is currently marketed by Pentron Clinical. Both products are acetone based and utilize the same adhesive monomer. B1P Adhesive differs in that it incorporates glutaraldehyde as a desensitizer, can be stored at ambient temperature, has both a bottle and a single dose configuration, and requires the use of only one coat.

B1P Adhesive functions in a manner similar to and is intended for the same use as Optibond Solo Plus 2 that is currently marketed by Kerr Corporation. Both products can be stored at ambient temperature, are both applied in a single coat, utilize filler technology to increase bond strength, and are both offered in a bottle and a single dose configuration. B1P Adhesive differs in that it uses a different adhesive monomer and it contains glutaraldehyde as a desensitizer.

B1P Adhesive functions in a manner similar to and is intended for the same use as IBond Total Etch that is currently marketed by Heraeus Kulzer GmbH. Both products contain glutaraldehyde as a desensitizing agent, require the use of only one coat, bond to both dentin and enamel, employ filler technology to increase bond strength, require the use

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of an etching agent and can both be stored at ambient temperature. B1P Adhesive differs in that it may be dual cured when mixed with the dual cure activator, and employs different main adhesive components.

Non-Clinical Test Data

Biocompatibility studies have been completed according to ISO 10993, which demonstrates that B1P Adhesive is safe for its intended use.

This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of B1P Adhesive compared to the predicate devices. The characteristics evaluated include direct and indirect bonding strengths.

Clinical Testing

Clinical testing has not been conducted on this product.

Conclusion:

Based upon biocompatibility tests, similar technological characteristics to the predicate devices and bench testing, the clinical performance of B1P Adhesive is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like bird with three curved lines representing its wings. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pentron Clinical C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

AUG - 1 2011

Re: K111431

Trade/Device Name: BIP Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 20, 2011 Received: May 23, 2011

Dear Ms. Garman: ·

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 – Ms. Garman

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

( 11 431

Device Name: B1P Adhesive

Indications For Use:

B1P Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following:

Direct Applications

Direct bonding to dentin and/ or enamel .
Bonding composite to composite, porcelain and/ or metal .
. Opaquing metal (used in conjunction with an opaque resin stain or cement)
Bonding with dual cure and self cure composite resins, such as cements and core build up . materials
Amalgam sealing
Dentin sealing ●

Indirect applications

Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, inlays, ● onlays and veneers (used in conjunction with resin luting agents)
Bonding of fiber and metal posts (in conjunction with resin luting agents) ●

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

rrence of CDRH, Office of Device Evaluation (ODE)

Susan Fraser

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

510(k) Number: K111431

Page 1 of 1

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.