Veneers. .
. Self-cure, dual-cure, light-cure resin cements and core buildup materials.
Porcelain, ceramic (including zirconia-based, lithium disilicate-based and . alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.
. Endodontic posts.
Cavity sealing as a pretreatment for indirect restorations. .

Device Description

OptiBond eXTRa Universal is a two-component universal adhesive system including a PRIMER and an ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond eXTRa Universal is compatible with total etch and selective etch techniques. The OptiBond eXTRa Universal ADHESIVE is 15% filled with 0.4 micron barium glass to help reinforce bond strength.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the device "OptiBond eXTRa Universal". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study design to meet those criteria as would be typical for an AI/ML device.

However, based on the non-clinical performance data and the comparison table, we can infer the acceptance criteria and the "study" (bench testing) that proves the device meets (or is substantially equivalent to) those criteria.

Here's the breakdown:

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

Since this is a substantial equivalence submission for a dental bonding agent and not an AI/ML device, the "acceptance criteria" are implied by demonstrating performance similar to the predicate device. The primary performance metric mentioned is shear bond strength to various substrates, which would have implicit targets aligned with the predicate's known performance.

Acceptance Criteria (Implied)	Reported Device Performance (OptiBond eXTRa Universal)
Shear Bond Strength: Performance similar to predicate OptiBond XTR in self-etch mode across various substrates (enamel, dentin, composite, ceramic, metal, amalgam) in all etching modes (self-etch, total-etch, selective-etch).	"The performance of OptiBond eXTRa Universal in any mode is statistically equivalent to predicate device OptiBond XTR in self-etch mode."
Biocompatibility: Meet ISO 10993 standards.	"Biocompatible per ISO 10993" (specifically mentions ISO 10993-1, -3, -5, -6, -10)
Risk Management: Compliance with ISO 14971.	"ISO 14971:2007 Risk Management"
Adhesion to Tooth Structure: Meet ISO 29022 standards.	"ISO 29022:2013* Dentistry Adhesive-Notched Edge Sheer Bond Strength Test - Testing of Adhesion to Tooth Structure"
Functional Equivalence: Compatibility with self-cure/dual-cure resin cements and core build-up materials.	The device's chemistry allows for compatibility with all self-cure or dual-cure resin cements and core build-up materials.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for the shear bond strength testing. It states: "Bench testing was conducted on a variety of self-cure or dual-cure resin cements and core-build up materials." and "OptiBond eXTRa Universal has been tested for its shear bond strength against a variety of materials (including enamel, dentin, and common substrates) in all etching modes."

Sample Size: Not explicitly stated. The phrase "a variety of" implies multiple samples per test condition.
Data Provenance: The testing appears to be retrospective (conducted by the manufacturer, Kerr Corporation, likely in a lab environment). The country of origin for the data is not specified, but the manufacturer is based in Orange, California, USA.

The document also mentions these relevant standards for testing:

ISO 10993-1: 2009 Biological Evaluation of Medical Devices
ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in Vitro Cytotoxicity
ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation
ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
ISO 14971:2007 Risk Management
ISO 29022:2013* Dentistry Adhesive-Notched Edge Sheer Bond Strength Test - Testing of Adhesion to Tooth Structure

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is a dental bonding agent, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for its performance is derived from standardized physical and chemical tests (e.g., measuring bond strength, cytotoxicity).

4. Adjudication method for the test set

This is not applicable as there is no expert adjudication process for this type of device and its performance testing. Performance is measured objectively through lab tests.

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

This is not applicable. This is not an AI/ML device, and no MRMC study was conducted. There is no human-in-the-loop performance with this product.

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

This is not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device's performance is established through objective laboratory measurements based on international standards for dental materials and biocompatibility:

Shear bond strength values: Measured using standardized methods (e.g., ISO 29022).
Biocompatibility test results: Measured as per ISO 10993 standards (e.g., cytotoxicity, genotoxicity, irritation).
Chemical composition compatibility: Verified through material science and chemical analysis.

8. The sample size for the training set

This is not applicable. This is a physical medical device (dental bonding agent), not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for this type of device.

Summary

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November 7, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the words in a sans-serif font.

Kerr Corporation % Ardrena Jackson Senior Regulatory Affairs Specialist Sybron Dental Specialties 1717 W. Collins Ave Orange, California 92867

Re: K182162

Trade/Device Name: OptiBond eXTRa Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 8, 2018 Received: August 10, 2018

Dear Ardrena Jackson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Digitally signed by Mary S. Runner -S3 Mary S. Runner -S3 12:56:12 -05'00' For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below

510(k) Number (if known) K182162

Device Name OptiBond eXTRa Universal

Indications for Use (Describe)

Direct Bonding Applications

· Light-cured composite and compomer restorations.
· Composite/ceramic/metal repairs.
· Cavity sealing for amalgam restorations.
· Sealing of hypersensitive and/or exposed root surfaces.
· Core build-ups (self-cured, light-cured, or dual-cured).

Indirect Bonding Applications

· Veneers.
· Self-cure, dual-cure, light-cure resin cements and core buildup materials.
· Porcelain, ceramic (including zirconia-based, lithium disilicate-based and alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.

• Endodontic posts.

· Cavity sealing as a pretreatment for indirect restorations.
Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510K K182162

Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo consists of 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 smaller font. The logo is simple and professional, and it is likely used to represent the company's brand.

OptiBond eXTRa Universal

1. Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

Contact Person:	Ardrena Jackson
Telephone Number:	714-516-7491
Fax Number:	909-962-5694
Date Prepared:	August 8, 2018

1. Device Name:

Classification Name	Resin tooth bonding agent
FDA CDRH Panel	Dental
Product Code	KLE
Regulation Number	872.3200
Class #	II

1. Predicate Device: OptiBond XTR (K101423)
1. Description of Device:

1. Indications for Use:

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Direct Bonding Applications

Light-cured composite and compomer restorations. .
. Composite/ceramic/metal repairs.
o Cavity sealing for amalgam restorations.
Sealing of hypersensitive and/or exposed root surfaces. .
. Core build-ups (self-cured, light-cured, or dual-cured).

Indirect Bonding Applications

Veneers. .
. Self-cure, dual-cure, light-cure resin cements and core buildup materials.
Porcelain, ceramic (including zirconia-based, lithium disilicate-based and . alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.
. Endodontic posts.
Cavity sealing as a pretreatment for indirect restorations. .

Summary of Non-Clinical Performance Data: 6.

The technological characteristics of subject device OptiBond eXTRa Universal is substantially equivalent to the predicate OptiBond XTR (K101423). Bench testing was conducted on a variety of self-cure or dual-cure resin cements and core-build up materials. The following performance tests were completed during the product lifecycle:

Non-clinical performance data includes testing for shear bond strength to various substrates. The data analyzed from the various tests substantiate that OptiBond eXTRa Universal performs similar to the predicate OptiBond XTR (K101423). The following standards were utilized for non-clinical performance testing of OptiBond eXTRa Universal :

· ISO 10993-1: 2009 Biological Evaluation of Medical Devices
· ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in Vitro Cytotoxicity
· ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation
ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
· ISO 14971:2007 Risk Management
ISO 29022:2013* Dentistry Adhesive-Notched Edge Sheer Bond Strength TestTesting of Adhesion to Tooth Structure

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Summary of Technological Characteristics and Device Comparison: 7.

The proposed OptiBond eXTRa Universal has similarities in performance characteristics and design features as compared to the predicate. The nonclinical performance testing demonstrates that the OptiBond eXTRa Universal performs as well as the predicate device OptiBond XTR (K101423). OptiBond eXTRa Universal has been tested for its shear bond strength against a variety of materials (including enamel, dentin, and common substrates) in all etching modes. Additional conformational biocompatibility testing was performed on the proposed OptiBond eXTRa Universal. The first difference in technological characteristics between the two devices is the replacement of one of the monomers in the formulation to another monomer that has the same function. The other difference in technological characteristics is the difference in techniques that the devices are marketed for. While predicate OptiBond XTR is for self-etch techniques, OptiBond eXTRa Universal can also be used in total and selective etch techniques. These technological differences were evaluated by testing the in-vitro shear bond strength of OptiBond eXTRa Universal using all etching techniques and comparing the performance in all modes to the predicate OptiBond XTR. The performance of OptiBond eXTRa Universal in any mode is statistically equivalent to predicate device OptiBond XTR in self-etch mode and does not raise concerns of safety and effectiveness. The differences in the formulation and the differences in application techniques do not raise concerns of safety and effectiveness. and demonstrate the subject device is at least as safe and effective as the legally marketed predicate device.

Element	PredicateOptiBond XTR	Subject DeviceOptiBond eXTRa Universal
510(k)	K101423	K182162
Manufacturer	Kerr Corporation	Kerr Corporation
Trade Name	OptiBond XTR	OptiBond eXTRa Universal
Target Users	Licensed Dental Professionals	Licensed Dental Professionals
Common Name	Bonding Agent	Same
ClassificationName	Resin Tooth Bonding Agent	Same
FDA Class	II, 21 CFR 872.3200	Same
Product Code	KLE	Same
DeviceDescription	OptiBond XTR is a two-component self-etch universal adhesive system including a self-etch PRIMER and a universal ADHESIVE. The self-etch primer provides effective etching to uncut enamel and dentin, without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure. The adhesive component is 15% filled with 0.4	OptiBond eXTRa Universal is a two-component universal adhesive system including a self-etch PRIMER and a universal ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond
Element	PredicateOptiBond XTR	Subject DeviceOptiBond eXTRa Universal
	micron barium glass to helpreinforce bond strength. Thematerial's chemistry allows forcompatibility with all self-cure ordual-cure resin cements and corebuild-up materials. Dentists cantherefore utilize OptiBond XTRfor their direct procedures withoutthe need for a secondary bondingsystem.	eXTRa Universal is compatible withtotal etch and selective etchtechniques. The OptiBond eXTRaUniversal ADHESIVE is 15% filledwith 0.4 micron barium glass to helpreinforce bond strength. Thematerial's chemistry allows forcompatibility with all self-cure ordual-cure resin cements and corebuild-up materials. Dentists cantherefore utilize OptiBond eXTRaUniversal for their direct and indirectprocedures without the need for asecondary bonding system.
Intended Use	Resin tooth bonding agent used indirect and indirect bondingapplications	Resin tooth bonding agent used indirect and indirect bondingapplications
Indications forUse	OptiBond XTR is a two-component self-etch universaladhesive system designed to beused for all direct and indirectapplications including, but notlimited to, the following:	Direct Bonding Applications• Light-cured composite andcompomer restorations.• Composite/ceramic/metal repairs.• Cavity sealing for amalgamrestorations.• Sealing of hypersensitive and/orexposed root surfaces.• Core build-ups (self-cured, light-cured, or dual-cured).
	Direct Applications• Light-cured composite andcompomer restorations• Composite/ceramic/metal repairs• Cavity sealing for amalgamrestorations• Sealing of hypersensitive and/orexposed root surfaces• Core build-ups (self-cured, light-cured or dual-cured)	Indirect Bonding Applications• Veneers.• Self-cure, dual-cure, light-cureresin cements and core buildupmaterials.• Porcelain, ceramic (includingzirconia-based, lithium disilicate-based and alumina-based),composite, and metal-based(including precious and non-preciousmetal inlays, onlays, crowns,bridges.• Endodontic posts.• Cavity sealing as a pretreatment forindirect restorations.
	Indirect applications• Veneers• Porcelain, composite, and metal-based (including zirconia-basedand alumina-based) inlays, onlays,crowns, bridges• Endodontic posts• Cavity sealing as a pretreatmentfor indirect restorations
Element	PredicateOptiBond XTR	Subject DeviceOptiBond eXTRa Universal

Principles ofOperation	Primer is applied to tooth structureto etch and prepare the surface,then adhesive is appliedfacilitating adhesion to therestoration through micro-mechanical interlocking andchemical bonding	Same
CuringMechanism	Photo-initiation	Same
Bonding AgentType	2 component system(primer and adhesive)	Same
Technique	Self Etch	Self-etch, Total-etch, Selective-etch
Resin Type	methacrylate, GPDM	Same
Cure Time	Optilux 501 - 10 secondsL.E.Demetron I - 10 secondsL.E.Demetron II - 5 secondsDemi/Demi Plus/Demi Ultra - 5secondsFor all other lights seemanufacturer's recommendation.	Same
SubstrateMaterialCompatibility	Dentin, enamel, composite,ceramic, metal, amalgam	Same
Biocompatibility	Biocompatible per ISO 10993	Same
Storageconditions	Refrigerate upon receipt, between2 o - 8oC	Same
Shelf Life	2 years	Same
Accessories	Mixing well, applicator brushes	Same
Packaging Type(DeliverySystem)	Bottle, Unidose (nonsterile)	Same

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1. Clinical Performance Data: The company did not conduct clinical performance testing for OptiBond eXTRa Universal.
1. Conclusion as to Substantial Equivalence: Based on technology, intended use, biocompatibility testing and non-clinical performance testing, the subject device OptiBond eXTRa Universal (K182162) is substantially equivalent to the predicate device OptiBond XTR (K101423).

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.