Interface "" is a ceramic primer/ conditioner, which allows the clinician to bond any type of ceramic (including newer high strength ceramic materials) to a tooth substrate. Interface "M when used in conjunction with a resin adhesive can be used for ceramic and ceramic to tooth repairs, as well as bonding ceramic inlays, onlays, crowns and veneers.

Interface ™ is to be used as a ceramic primer/ conditioner allowing bonding to ceramic, dentin and enamel all at the same time. With Interface "1", any dental ceramic can be repaired safely in the mouth without the use of dangerous hydrofluoric acid.

Device Description

Interface™ is a ceramic primer which allows the clinician to bond any type of ceramic to a tooth substrate without the pre-application of hydrofluoric acid. Interface™ is prepared by mixing one drop of each component and then waiting 30 seconds for the materials to co-mix. The advantage of being able to mix these chemistries just prior to use, assures the clinician that the mixture is always fresh. Since both chemistries are separate prior to mixing the shelf life of the materials is very stable. In comparison, traditional hydrolyzed silane has an extremely short shelf life which can unknowingly jeopardize bond strengths once near expiration or expired.

Interface™ can be used to prime/ condition tooth structure prior to repairing a tooth to ceramic restoration. The need to acid etch the substrates prior to bonding with either phosphoric or hydrofluoric acids is not necessary. As a result this eliminates any confusion for the clinician on how to prep the restoration for successful bonding.

Interface™ can be used to bond to ceramic, dentin and enamel all at the same time.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) submission for a dental bonding adhesive named "Interface™," along with the FDA's response letter.

The submission primarily describes:

The device name, common name, classification, and product code.
Identification of a legally marketed predicate device (hydrolyzed silane).
A description of the "Interface™" device, highlighting its advantages over the predicate device, particularly its ability to bond to ceramic, dentin, and enamel without the need for hydrofluoric or phosphoric acid etching.
The FDA's letter of substantial equivalence, allowing the device to be marketed.
Indications for Use for the "Interface™" device.

There is no mention of:

Acceptance criteria (e.g., target performance metrics like sensitivity, specificity, accuracy, bond strength thresholds).
Any studies conducted to demonstrate the device meets specific performance criteria.
Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
MRMC studies or human-in-the-loop performance.
Information about training sets or how ground truth was established for development.

Therefore, I cannot provide the requested table and information based on the given text.

Summary

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

SH 10 of 14

K053103

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 Tele- (877) 273-9123

510 (K) Submission Date: November 3, 2005

Contact Person: Chris Kulton

Device Name:
Trade Name:	Interface™
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

Raw silane (3-(Trimethoxysily)propyl methacrylate, 98%) hydrolyzed with acetic acid is an industry standard priming agent that is applied to prime ceramic surfaces pre-etched with hydrofluoric acid. This system combination is used to prepare inorganic ceramic surfaces prior to bonding with an organic resin based adhesive or cement. Historically hydrolyzed silane has been used to increase bonding strength, by acting as a coupling agent between the inorganic ceramic surface and the organic resin based restorative material. This basic coupling agent chemistry is only used to prime ceramics prior to bonding with an adhesive or cement. When

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510K Abbreviated Submission for Interface™ Apex Dental Materials, 23329 Mallard Court Decr Park, IL. 60010

Continued:

repairing ceramic restorations involving tooth structure, this system does not have the capability to prime or condition exposed tooth substrate. This must be performed in a separate application protocol involving tooth etching conditioners such as a phosphoric acid gel.

DESCRIPTION OF APPLICATION DEVICE

Interface™ can be used to bond to ceramic, dentin and enamel all at the same time.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB I

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

Re: K053103 Trade/Device Name: Interface™ Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 05, 2005 Received: January 11, 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. Iabeling, 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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chris S. Liem, Ph.D.

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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SH 4 of 14

510K Abbreviated Submission for Interface™ Apex Dental Materials, 23329 Mallard Court Decr Park, IL. 60010

Indications for Use 11 053103

510(K) Number (if known):

Device name: Interface™

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

Suver Runne

Over- The- Counter Use

(Optional Format 1-2-96)

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.