SURPASS™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light-cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resinmodified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.

Indications For Use:

Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials.
Indirect Restorations: to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resin-modified glass ionomer cement.
Desensitization: to treat hypersensitive and/or exposed root surfaces.
To bond in a post and core.

Device Description

SURPASS™ is a light cured (free radical polymerization), self-etching dental adhesive system. designed to provide a dentist with an increased ease of use that is less technique sensitive. The bonding system combines both the etchant and primer applications into one simple step followed by a thin layer of unfilled bonding resin. Thus, allowing for more predictable clinical results without sacrificing bond strength integrity.

SURPASS™ 2 is an ethanol-based adhesive that is dependent on the prepared surface of its conditioner (SURPASS™ 1). This acidic conditioner application is a procedure that is very similar to the phosphoric acid etching process of dentin/enamel substrate in the ECLIPTOMER (510K number K945604, Bisco, Inc.) system. Applying the SURPASS™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol. Once SURPASS™ 2 has been dried a thin layer of SURPASS™ 3 is applied to the SURPASS™ 2 surface and light cured for 20 seconds. The SURPASS™ 3 acts as a superior tie layer between SURPASS™2 and the filling material of choice.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SURPASS™ Dental Bonding Adhesive Resin, based on the provided document:

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria in the manner one might find for a novel, high-risk device. The primary "acceptance criteria" here relate to the device's physical properties being comparable to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Device	SURPASS™ is "substantially equivalent to ECLIPTOMER (510K number K945604, Bisco, Inc.)" based on physical testing observations and analysis, including shear bond strength to dentin and enamel, similar handling, same indication for use, and same base composition as Simplicity® Adhesive System (K020570).
Shear Bond Strength (to dentin and enamel)	"similar to" ECLIPTOMER
Similar Handling Characteristics	"similar handling to" ECLIPTOMER
Predictable Clinical Results without sacrificing bond strength integrity	Achieved through the design of a self-etching system that combines etchant and primer, followed by a thin layer of unfilled bonding resin.
Increased Ease of Use, less technique sensitive	Achieved through the design of a self-etching system that combines etchant and primer.
Long-time industry standards for individual components	Individual components of SURPASS™ are stated to be "long-time industry standards and are utilized in numerous dental bonding systems currently marketed in the United States."

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

The document does not explicitly state the sample size used for the "physical testing observations and analysis, including shear bond strength to dentin and enamel." It only mentions that this testing was performed to support the substantial equivalence claim.

The data provenance is not specified beyond indicating it was performed by Apex Dental Materials, Inc. It's typical for such tests to be conducted in a laboratory setting, and the nature of the tests (physical properties) suggests a prospective experimental study rather than retrospective clinical data. The country of origin for the data is implicitly the United States, where the manufacturer is located.

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

This information is not provided in the document. For physical property tests of dental bonding agents, "ground truth" is typically established through standardized laboratory measurement protocols and material science principles, rather than expert clinical consensus as might be seen for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes, which is not the primary focus of this submission. The evaluation is based on objective physical property measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is for evaluating human performance, often in diagnostic imaging, and is not relevant for the physical properties validation of a dental bonding agent.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the context of this device. A dental bonding adhesive is a material, not a "device" in the sense of a software algorithm or an automated diagnostic tool that would have a standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the SURPASS™ device is based on objective measurements of physical properties, specifically focusing on shear bond strength to dentin and enamel. This is compared against the known properties of the predicate device (ECLIPTOMER).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This device is a material, not an AI/ML algorithm that requires a training set. The submission describes the development of the adhesive system, but not a data-driven model training process.

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

As the concept of a training set is not applicable, this information is also not provided.

Summary

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107 4

KD6/981

JUL 3 1 2006

Abbreviated 510 (K) SUMMARY

As Required by the Safe Medical Devices Act of 1990

Apex Dental Materials, Inc. 23329 Mallard Court Deer Park, IL 60010 Phone: (877) 273-9123

July 12th, 2006 Abbreviated 510 (K) Submission Date:

II KLE

Chris Kulton Contact Person:

Device Name:

Trade Name: Common Name: Classification Name: SURPASS™ Dental Bonding Adhesive Resin Tooth Bonding Agent, per 21 CFR parts 872.3200

Classification:

Regulatory Class:
Product Code:

IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

PREDICATE DEVICE

ECLIPTOMER (510K number K945604, Bisco, Inc.) is a universal dental adhesive system that

is designed to bond composite to dentin, enamel, cast metals, treated porcelain and set amalgam.

This system is also designed for indirect techniques as well as amalgam bonding.

ECLIPTOMER (510K number K945604, Bisco, Inc.) is an acetone-based primer that is

dependent on a clean etched dentin/enamel surface that is visibly moist. Its physical properties

are similar to the applicant device and uses are identical. Like the applicant device,

ECLIPTOMER (510K number K945604, Bisco, Inc.) is one component used in conjunction with

Abbrevaited 510K Submission for SURPASSTM Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010

Page 12 of 15

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K06/981
2 of 4

a complete dental bonding system. It hardens by a light cure polymerization mechanism employing a photo initiator, and a chemical activator.

Summary continued:

DESCRIPTION OF APPLICATION DEVICE

Abbrevaited 510K Submission for SURPASSTM Apex Dental Materials. 23329 Mallard Court Deer Park, IL 60010

Page 13 of 15

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K06/98/
3074

Summary continued:

INTENDED USES OF APPLICANT DEVICE

PERFORMANCE CHARACTERISTICS and CONCEPTS

SURPASS™ has similar handling to the ECLIPTOMER (510K number K945604, Bisco, Inc.) adhesive system. From the physical testing observations and analysis, including shear bond strength to dentin and enamel, we suggest that SURPASS™ is substantially equivalent to ECLIPTOMER (510K number K945604, Bisco, Inc.). Along with this we would suggest the individual components of SURPASS™ are long-time industry standards and are utilized in numerous dental bonding systems currently marketed in the United States (see Confidential Formulation Details on page 5). In addition, SURPASS™ is essentially our Simplicity® Adhesive System (510K: K020570) with an added bonding resin (SURPASS™ 3). SURPASS™ has the same indication for use and same base composition as the Simplicity® Adhesive System

(510K: K020570).

Abbrevaited 510K Submission for SURPASSTM Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010

Page 14 of 15

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K06/98/
4084

Indications for Use

510(K) Number (if known):

SURPASSTM Device name:

Indications For Use:

. Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials.
Indirect Restorations: to seal a preparation when using a light-cured, self-cured or dual-cured . composite cement or glass ionomer or resin-modified glass ionomer cement.
. Desensitization: to treat hypersensitive and/or exposed root surfaces.
To bond in a post and core .

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

Concurrence of CDRL, Office of Device Evaluation (ODE)

Prescription use X (Per 21 CFR 801.109 OR

Over- The- Counter Use

(Optional Format 1-2-96)

Page 4 of 15

Abbrevaited 510K Submission for SURPASSTM Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2006

Mr. Chris Kulton Apex Dental Materials, Incorporated 23329 Mallard Court Deer Park, Illinois 60010

Re: K061981

Trade/Device Name: Surpass™M Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 12, 2006 Received: July 17, 2006

Dear Mr. Kulton:

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.

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Page 2 - Mr. Kulton

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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K061981

Indications for Use

510(K) Number (if known):

SURPASS™ Device name:

Indications For Use:

· Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials.
Indirect Restorations: to seal a preparation when using a light-cured, self-cured or dual-cured . composite cement or glass ionomer or resin-modified glass ionomer cement.
Desensitization: to treat hypersensitive and/or exposed root surfaces. ◆
To bond in a post and core .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)

Prescription use X (Per 21 CFR 801.109

Apex Dental Materials,

23329 Mallard Court

Deer Park, IL 60010

Abbrevaited 510K Submission for SURPASSTM

Over- The- Counter Use

(Optional Format 1-2-96)

Mubey for MSK Page 4 of 15

..un Sign-Off)
on of Anesthesiology, General Hospital.
cuon Control, Dental Devices

K06198)

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.