The EZ-Fill® Xpress Epoxy Root Canal Cement System is an obturation system for filling straight and minimally curved canals. The bi-directional spiral (cement carrier that fully coats the canal, but prevents excess cement form exiting apically) and epoxy root canal cement, combined with a single point technique, creates a seal equivalent to lateral condensation and thermoplastic gutta percha. The contents of the kit are identical except that '2 - Dual Chambered Syringes containing 9.5 gm of root canal sealer' and '20 - Mixing Tips' replace the '7.5 gm - Epoxy Root Canal Cement Gel, 8.0 gm - Powder (Epoxy Root Canal Cement), and 1 Measuring Scoop.' The full list of contents is as follows: 4 - Color Coded to ISO Size 25 Bi-Directional Spirals (1 - 21mm length and 3 - 25 mm length), 2 - Dual Chambered Syringes containing 9.5 gm root canal sealer, 20 - Mixing Tips.

AI/ML Overview

The provided document describes the EZ-Fill® Xpress Epoxy Root Canal Cement System and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in the format requested.

The document focuses on demonstrating substantial equivalence through:

Comparison of device description, intended use, and technological characteristics to predicate devices.
Bench testing to show compliance with international standards (ADA Specification No.57 and ISO 6876) for physical properties.
Biocompatibility literature to show no new safety concerns compared to predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are Not Applicable (N/A) based on the provided text, as a direct study demonstrating achievement of criteria is not presented.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ADA Specification No.57 (Dental Root Canal Filling Material)	Meet/exceed ADA Specification No.57
ISO 6876 (Endodontic Filling Materials)	Meet/exceed ISO 6876
Specific Physical Properties (Flow, Film Thickness, Dimensional Stability, Solubility, Disintegration)	Meet/exceed these properties as per the above standards
Bi-Directional Spiral Dimensional Specifications (implied)	Checked to meet all required specifications
Biocompatibility (implied: no new safety concerns)	Literature shows no new safety/biocompatibility concerns compared to predicate devices

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

Sample Size: Not specified. The document only mentions "Bench Testing performed" without detailing the number of samples or tests conducted.
Data Provenance (country of origin, retrospective/prospective): Not specified.

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

Not Applicable. Bench testing against pre-defined physical property standards does not typically involve expert ground truth establishment in the same way clinical or diagnostic studies do. The "ground truth" here is the standard itself.

4. Adjudication method for the test set

Not Applicable. See point 3.

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

No. The document explicitly states: "Discussion of Clinical Tests Performed: Not Applicable." This is a material testing for a root canal cement, not a diagnostic AI device.

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

Not Applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For physical properties, the ground truth is based on the requirements and methodologies outlined in ADA Specification No.57 and ISO 6876.
For biocompatibility, the ground truth is established by biocompatibility literature and Material Safety Data Sheets, indicating that the materials do not raise new safety concerns compared to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. See point 8.

Summary

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FEB 6 2007

EXHIBITHEF

510(K) SUMMARY

This summary of 5!0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: 1063856

1. Submitter's Identification:

Essential Dental Systems, Inc. 89 Leuning Street South Hackensack, NJ 07606

Date Summary Prepared: December 27, 2006

Contact: Mr. Brian Rasimick

Name of the Device: 2.

EZ-Fill® Xpress Epoxy Root Canal Cement System

3. Predicate Device Information:

The Bi-Directional Spiral & Epoxy Root Canal Cement System, K# 992727, MDS, New York, NY
AH-Plus™ Root Canal Sealer, K# 960548, Dentsply International, York, PA

4. Device Description:

The device description is identical to that of the predicate device, Bi-directional Spiral & Epoxy Root Canal Cement System:

The contents of the kit are identical except that '2 - Dual Chambered Syringes containing 9.5 gm of root canal sealer' and '20 - Mixing Tips' replace the '7.5 gm -

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Epoxy Root Canal Cement Gel, 8.0 gm - Powder (Epoxy Root Canal Cement), and 1 Measuring Scoop.' The full list of contents is as follows:

4 - Color Coded to ISO Size 25 Bi-Directional Spirals (1 - 21mm length and 3 - 25 mm length)

2 - Dual Chambered Syringes containing 9.5 gm root canal sealer 20 - Mixing Tips

5. Intended Use:

The EZ-Fill® Xpress Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.

6. Comparison to Predicate Devices:

The subject device is a derivative of EZ-Fill®(component of the Bi-Directional Spiral & Epoxy Root Canal Cement System). Both the EZ-Fill® and subject device are two-component epoxy/amine systems that use bismuth oxide as the primary radiopacifing agent. Both are applied to the tooth using the Bi-Directional spiral and used in conjunction with the same auxiliary materials in the root canal (i.e. gutta percha points).

Unlike traditional EZ-Fill®, the subject device is a gel/gel system rather than a powder/gel system. This is due to a change in the amine curing agent. The gel/gel formulation of the subject device is delivered by a dual chambered syringe as is the gel/gel formulation of AH-Plus™ Jet.

The subject device does not contain silver. Instead, the subject device contains three ingredients found in AH-Plus™ endodontic sealer - zirconium dioxide, fumed silica, and iron oxide,

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Bench Testing performed on the EZ-Fill® Xpress Epoxy Root Canal Cement System meet/exceed ADA Specification No.57 (Dental Root Canal Filling Material) and ISO 6876 (Endodontic Filling Materials) including physical properties such as flow, film thickness, dimensional stability, solubility and disintegration. Bi-Directional Spiral (reverse spiral drill) dimensional inspections are checked to meet all required specifications

Biocompatibility literature supplied with this 510(k) submission along with Material Safety Data Sheets, has shown that the EZ-Fill® Xpress Epoxy Root

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Canal System material, as well as the material contained in the predicate devices, do not raise any new safety/biocompatibility concerns.

8. Discussion of Clinical Tests Performed:

Not Applicable.

9. Conclusions:

The EZ-Fill® Xpress Epoxy Root Canal Cement System has the same intended use and similar technological characteristics as the predicate devices. Moreover, bench testing contained in this submission and clinical literature supplied demonstrate that any differences in their material formulations do not raise any new questions as to safety or effectiveness. Thus, the EZ-Fill® Xpress Epoxy Root Canal Cement System is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Essential Dental Systems, Incorporated C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

FEB 6 2007

Re: K063856

Trade/Device Name: EZ-Fill® Xpress Epoxy Root Canal Cement System Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: December 27, 2006 Received: December 28, 2006

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your booker on (1) I - device is substantially equivalent (for the indications for releved above and nove to legally marketed predicate devices marketed in interstate commerce use stated in the eneround date of the Medical Device Amendments, or to devices that provision in May 20, 1970, the made 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, Act (for) that ao not require spring apprect to the general controls provisions of the Act. The general therefore, market the device, babyect to annual registration, listing of devices, good Controle pro receive, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to stan access 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 -- Ms. Susan D. Goldstein-Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA s Issualled on a sacesuite complies with other requirements of the Act or that FDA nas made a decermination that your cred by other Federal agencies. You must comply with all the Act's requirements and regulations administers of the registration and listing (21 CFR Part 807); all the Act s requirements, mending, but not manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 801), good manatates and if applicable, the electronic product radiation Systems (QD) regalasses ons 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) I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket noutication. The IDA midning of bassantal vice 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 If you desire specific advice 10. Jour 2011 5. Also, please note the regulation entitled, Comaci the Office of Comphanes at (210) 216 at 1979. You may obtain other MISSIAN Information on your responsibilities under the Act from the Division of Small general information on your responsibilities Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octibal http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Exhibit B

Indications for Use

Page of

510(k) Number (if known):

Device Name: The EZ-Fill® Xpress Epoxy Root Canal Cement System

Indications For Use:

The EZ-Fill® Xpress Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.

1063856

Prescription Use _ x Use

Over-The Counter

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Rose

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Anastherstofngw, Graveral Hospital ontrol, Damal Devices

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.