(40 days)
K# 992727, K# 960548
Not Found
No
The description focuses on the physical components and material properties of a root canal filling system, with no mention of AI or ML.
Yes
This device is a cementing system used to seal root canals, which is a therapeutic intervention.
No
The device is an obturation system used for filling root canals, not for diagnosing conditions. Its function is to seal the root canals permanently.
No
The device description clearly outlines physical components like syringes, mixing tips, and bi-directional spirals, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent sealing of root canals following established endodontic procedures." This is a therapeutic procedure performed directly on a patient's body (within the root canal).
- Device Description: The device is a system for filling root canals with cement. This is a physical intervention, not a diagnostic test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, tissue, or other bodily fluids), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Bench Testing: The performance studies focus on physical properties of the cement and the spiral, which are relevant to its function as a filling material, not its diagnostic capabilities.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The EZ-Fill® Xpress Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.
Product codes
KIF
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 Canal System material, as well as the material contained in the predicate devices, do not raise any new safety/biocompatibility concerns.
Discussion of Clinical Tests Performed: Not Applicable.
Key Metrics
Not Found
Predicate Device(s)
K# 992727, K# 960548
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 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 -
1
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
2
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.
3
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.
4
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
5
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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Anastherstofngw, Graveral Hospital ontrol, Damal Devices