CONFORM™ is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations.

CONFORM™ is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORM™ can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORM™ is compatible with all other methacrylate based dental materials.

Device Description

CONFORM™ is a light activate (photo initiated, free radical polymerization), flowable hybrid composite material designed to act as a filling material in small restorations or as a liner material for larger restorations. CONFORM™ has been designed to provide a flowable material with a high level of thixotropic behavior. The material also contains fillers to optimize the cured strength and radiopacity properties.

CONFORM™ is a methacrylate (BisGMA) based material that has been designed to work effectively with methacrylate based adhesives and composites currently sold into the dental market.

AI/ML Overview

The provided text is a 510(k) summary for a dental material called CONFORM™ and a letter from the FDA regarding its clearance. It describes the device, its intended uses, and claims substantial equivalence to predicate devices based on "physical testing observations and analysis, including diametric tensile strength and compressive strength." However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets them, as these would typically involve specific metric thresholds, detailed study designs, and human reader performance data, none of which are present here.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or clinical study methods like MRMC or standalone performance.

The submission focuses on chemical composition similarities and basic physical properties to establish substantial equivalence, not on clinical performance metrics typically associated with AI/device acceptance criteria regarding diagnostic accuracy.

Here's what can be extracted based on the provided document, addressing the structure of your request where possible, but highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of acceptance criteria with specific quantitative thresholds. The "Performance Characteristics and Concepts" section states: "CONFORM™ has similar handling to the AELITEFLO® (510K number K955292, Bisco, Inc.) composite. From the physical testing observations and analysis, including diametric tensile strength and compressive strength, we suggest that CONFORM™ is substantially equivalent to AELITEFLO® (510K number K955292, Bisco, Inc.)."

This narrative indicates that the acceptance criteria revolved around demonstrating similar physical properties (handling, diametric tensile strength, and compressive strength) to the predicate device, AELITEFLO®. However, specific numeric ranges or targets for these properties are not disclosed in this summary.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Similar handling to AELITEFLO®	Similar handling
Similar diametric tensile strength to AELITEFLO®	Similar diametric tensile strength
Similar compressive strength to AELITEFLO®	Similar compressive strength
Substantially equivalent to AELITEFLO®	Substantially equivalent

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

Sample size for test set: Not reported in this document. The submission references "physical testing observations and analysis" but does not specify the number of samples or specimens tested.
Data provenance: Not specified. It can be inferred that the testing was conducted by Apex Dental Materials, Inc. (the manufacturer) as part of their submission process. The country of origin and whether it was retrospective or prospective is not stated.

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

Not applicable/Not reported. This type of information is typically relevant for diagnostic devices where human experts establish ground truth for clinical cases. For a dental material, the "ground truth" would be established through standardized physical property testing, not expert consensus on diagnostic images.

4. Adjudication method for the test set:

Not applicable/Not reported. As this pertains to physical properties, not clinical adjudication of cases.

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:

Not applicable. This is not an AI-powered diagnostic device; it is a dental filling material. Therefore, MRMC studies are not relevant in this context.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

For physical property testing (diametric tensile strength, compressive strength), the "ground truth" is typically established by standardized laboratory measurement protocols using calibrated equipment.

8. The sample size for the training set:

Not applicable. The concept of "training set" is for machine learning models. For a physical material, there isn't a training set in the same sense. The material formulation itself is developed based on chemical and material science principles, not machine learning.

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

Not applicable, as there is no "training set" in the context of this traditional medical device. The "ground truth" for the material's properties would be established through the initial R&D and quality control processes based on established material science standards.

Summary

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OCT 1 3 2006

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

July21st, 2006 510 (K) Submission Date: Chris Kulton Contact Person: Device Name: CONFORM™ Trade Name: Material, Tooth Shade, Resin Common Name: Tooth Shade Resin Material, per 21 CFR parts 872.3690 Classification Name: Classification: Regulatory Class: 2

IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

EBF

PREDICATE DEVICE

Product Code:

AELITEFLO® (Bisco, Inc. K955292) is a flowable composite material designed to act as a

cavity filling or lining material. This system is applied directly to bonded tooth surfaces to

effectively replace removed tooth structure.

AELITEFLO® (Bisco, Inc. K955292) is a methacrylate based composite material filled with

various inorganic glasses to provide strength, wear and radiopacity characteristics.

AELITEFLO® is a single paste material that is used directly with dental bonding systems. It

510K Submission for CONFORM™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010

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hardens by a photo initiated polymerization mechanism employing a light initiator, and a chemical activator.

Summary continued:

DESCRIPTION OF APPLICATION DEVICE

CONFORM™ is a methacrylate (BisGMA) based material that has been designed to work effectively with methacrylate based adhesives and composites currently sold into the dental market.

INTENDED USES OF APPLICANT DEVICE

CONFORM™ is a light-cured composite with flow characteristics that make it ideal for Class V restorations, as well as Class III, and small Class IV restorations. Other uses of this material are as a liner for Class I and II restorations, pit and fissure sealants, the repair of marginal defects, small core build-ups, porcelain repair, porcelain veneer cementation or as a flowable composite for bonding splints into place.

Class V .
Class III .
Cavity Liner .

510K Submission for CONFORM™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010

Page 12 of 14

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Pit and Fissure sealant ●
Porcelain repair .
. Margin repair
Core build ups .
. Buccal repair

Summary continued:

PERFORMANCE CHARACTERISTICS and CONCEPTS

CONFORM™ has similar handling to the AELITEFLO® (510K number K955292, Bisco, Inc.) composite. From the physical testing observations and analysis, including diametric tensile strength and compressive strength, we suggest that CONFORM™MM is substantially equivalent to AELITEFLO® (510K number K955292, Bisco, Inc.). Along with this we would suggest the individual components of CONFORM™ are long time industry standards and are utilized in numerous dental composite products currently marketed in the United States (see Confidential Formulation Details on page 5).

Equivalent Product and Manufacturer	Corresponding 510(k) Number
AELITEFLO® (Bisco, Inc.)	K955292
PERMAFLO® (Ultradent Products Inc.)	K974413

510K Submission for CONFORM™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010

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0C1 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K062157

Trade/Device Name: ConformTM Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 21, 2006 Received: July 31, 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. Chris 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" (21 CFR 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.

Scudette Y. Michelini Ond

Chiu S. Lin. PhD 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):

K062157

Device name:

CONFORMIM

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
	ion of Anesthesiology, General Hospital, Over, The- Counter Use
	ion Control, Dental Devices
	Number: K 062157 (Optional Format 1-2-96)

510K Submission for CONFORM™

Page 4 of 14

Apex Dental Materials,

23329 Mallard Court

Deer Park, IL 60010

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.