EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM

K063856 · Essential Dental Systems, Inc. · KIF · Feb 6, 2007 · Dental

Device Facts

• Record ID: K063856
• Device Name: EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
• Applicant: Essential Dental Systems, Inc.
• Product Code: KIF · Dental
• Decision Date: Feb 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Obturation system for filling straight and minimally curved root canals; utilizes bi-directional spiral cement carrier to coat canal walls while preventing apical extrusion; system consists of dual-chambered syringe containing epoxy/amine root canal sealer and mixing tips; used by dentists/endodontists in clinical settings; sealer applied in conjunction with gutta percha points; provides seal equivalent to lateral condensation and thermoplastic gutta percha; benefits patient by providing permanent root canal seal.

Clinical Evidence

No clinical data. Bench testing performed to verify physical properties including flow, film thickness, dimensional stability, solubility, and disintegration per ADA Specification No. 57 and ISO 6876. Biocompatibility supported by literature and Material Safety Data Sheets.

Technological Characteristics

Two-component epoxy/amine resin system; radiopacifiers include bismuth oxide and zirconium dioxide; additives include fumed silica and iron oxide; delivered via dual-chambered syringe with mixing tips; application via bi-directional spiral (reverse spiral drill); meets ADA Specification No. 57 and ISO 6876 standards.

Indications for Use

Indicated for permanent sealing of root canals following established endodontic procedures in patients requiring root canal therapy.

Regulatory Classification

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.

Predicate Devices

• Bi-Directional Spiral & Epoxy Root Canal Cement System (K992727)
• AH-Plus™ Root Canal Sealer (K960548)

Submission Summary (Full Text)

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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:

1. The Bi-Directional Spiral & Epoxy Root Canal Cement System, K# 992727, MDS, New York, NY

2. 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 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 qutta 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 -

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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 [phone] 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)

OR

(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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