SIMPLICITY™ 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 The bonding system combines both the etchant and primer applications into one sensitive. Thus, allowing for more predictable clinical results without sacrificing bond simple step. strength integrity.

SIMPLICITY™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light cured or self 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 resin-modified 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.

Device Description

SIMPLICITY™ 2 is an acetone based adhesive that is dependent on the prepared surface of its conditioner (SIMPLICITY™ 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 system. Applying the SIMPLICITY™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) submission for SIMPLICITY™ Dental Materials:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Similar handling characteristics to predicate device.	"SIMPLICITY™ has similar handling to the ECLIPTOMER..."
Shear bond strength to dentin similar to predicate device.	"physical testing observations and analysis, including shear bond strength to dentin... suggest that SIMPLICITY™ is substantially equivalent to ECLIPTOMER."
Shear bond strength to enamel similar to predicate device.	"physical testing observations and analysis, including shear bond strength to... enamel, we suggest that SIMPLICITY™ is substantially equivalent to ECLIPTOMER."
Overall substantial equivalence to predicate device.	"From the physical testing observations and analysis... we suggest that SIMPLICITY™ is substantially equivalent to ECLIPTOMER (Bisco, Inc.)."

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

Sample Size for Test Set: The document does not explicitly state a specific sample size for the "physical testing observations and analysis." It generally refers to "physical testing observations."
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) for a dental adhesive, this type of testing is typically prospective, conducted in a lab setting rather than on human subjects.

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

The document does not mention the use of experts to establish ground truth for the physical testing. Instead, the ground truth is based on the measured physical properties (e.g., shear bond strength) and comparison to the predicate device.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" for this type of device is based on quantifiable physical and chemical properties, not expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. SIMPLICITY™ is a dental adhesive, and its performance is assessed through physical property testing, not human interpretation of cases.

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

Not applicable. SIMPLICITY™ is a physical dental material, not an algorithm or AI system. Its performance is inherent to its material properties and chemical composition.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for SIMPLICITY™ is based on quantifiable physical and chemical properties, specifically "shear bond strength to dentin and enamel." The performance of the predicate device, ECLIPTOMER, serves as the benchmark against which the new device (SIMPLICITY™) is compared.

8. The Sample Size for the Training Set

Not applicable. SIMPLICITY™ is a physical dental material and does not involve AI or machine learning algorithms that require a training set.

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

Not applicable. As SIMPLICITY™ is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

Summary

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APR 2 4 2002

K020570

510K Submission for SIMPLICITY™ Apex Dental Materials, 603 Berkley Court Schaumburg, IL. 60194

510 (K) SUMMARY

As Required by the Safe Medical Devices Act of 1990

Apex Dental Materials, Inc. 603 Berkley Court Schaumburg, IL, 60194 Phone: (847) 490-1014

510 (K) Submission Date: February 20, 2002

Contact Person: Chris Kulton

Device Name: SIMPLICITY™ Trade Name: Common Name: Dental Bonding Adhesive Classification Name: Resin Tooth Bonding Agent, per 21 CFR parts 872.3200 Classification: Regulatory Class: II Product Code: KLE

IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

PREDICATE DEVICE

ECLIPTOMER (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 (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 is one component used in conjunction with a complete dental bonding system. It hardens by a light cure polymerization mechanism employing a light initiator, and a chemical activator.

SH 12 of 15

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510K Submission for SIMPLICITY™ Apex Dental Materials, 603 Berkley Court Schaumburg, IL. 60194

Summary continued:

DESCRIPTION OF APPLICATION DEVICE

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510K Submission for SIMPLICITY™ Apex Dental Materials, 603 Berkley Court Schaumburg, IL. 60194

Summary continued:

INTENDED USES OF APPLICANT DEVICE

PERFORMANCE CHARACTERISTICS and CONCEPTS

SIMPLICITY™ has similar handling to the ECLIPTOMER (Bisco, Inc.) adhesive system. From the physical testing observations and analysis, including shear bond strength to dentin and enamel, we suggest that SIMPLICITY™ is substantially equivalent to ECLIPTOMER (Bisco, Inc.). Along with this we would suggest the individual components of SIMPLICITY™ 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).

Equivalent Product and Manufacturer

Corresponding 510(k) Numbers

ECLIPTOMER (Bisco, Inc.)

K945604

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/13 description: The image shows a partial view of a logo or emblem. The visible portion includes the stylized depiction of an eagle or similar bird-like figure with outstretched wings, rendered in a thick, black line. To the left of the bird figure, there is text arranged vertically, which appears to be part of the phrase "DEPARTMENT OF HEALTH & HUMAN". The text is also in black and is oriented to be read from bottom to top.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2002

Mr. Chris Kulton Apex Dental Materials, Incorporated 603 Berkley Court Schaumburg, Illinois 60194

Re: K020570

Trade/Device Name: SIMPLICITYTM Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 20, 2002 Received: February 21, 2002

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.

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 - Mr. Chris Kulton

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 and additionally 21 CFR Part 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 Part 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,

A. Ulatowski Tim 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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510K Sybmission for SIMPLICITY™ Apex Dental Materials, 603 Berkley Court Schaumburg, IL. 60194

Indications for Use

510(K) Number (if known):

Device name: SIMPLICITY™

Indications For Use:

(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)

Susan Renner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices NOW IS 510(k) Number_

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.