(19 days)
EndoREZ is designed to be used with EndoREZ Points and/or gutta percha for the filling of cleaned and shaped root canals. EndoREZ, in conjunction with a master cone and accessory cones (as needed), provides optimum sealing. Although EndoREZ Points are recommended, EndoREZ may be used with all conventional endodontic obturation techniques.
A unique biocompatible methacrylate-based root canal sealer/filler, EndoREZ is a two part, mixed, dual cure material with optional EndoREZ Accelerator included. EndoREZ has hydrophilic characteristics providing excellent penetration into dentinal tubules. This allows for improved sealing properties combined with ease of placement and removal. Radiopacity equivalent to gutta percha simplifies radiographic interpretation. EndoREZ does not compromise the function of dentin bonding agents or luting resin polymerization.
The document describes a 510(k) submission for the EndoREZ® Dual Cure with Accelerator, a dental device for root canal filling. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness through a clinical study with detailed acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set information is either not applicable or not provided in this type of regulatory document.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable / Not Provided.
This document is a 510(k) Summary, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove a device meets specific performance acceptance criteria through a standalone clinical study with reported metrics. The submission focuses on comparing characteristics and safety to an existing device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None explicitly stated related to performance metrics for a specific clinical outcome. | The document states "The results of biocompatibility testing demonstrate that the EndoREZ Dual Cure used with the EndoREZ Accelerator is compatible with its intended use as a root canal filler/sealer." This is a qualitative statement about compatibility, not a quantitative performance metric against an acceptance criterion. |
| Implicit criterion: Substantial Equivalence to Predicate Device (EndoREZ Dual Cure, K042756) | The conclusion states: "EndoREZ Dual Cure used with the EndoREZ Accelerator... is substantially equivalent to the EndoREZ Dual Cure used alone... The two products are composed of nearly the same materials, have the same intended use and technological characteristics, and both are safe and effective when used for the indications described." |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable / Not Provided.
No test set or clinical study with a specified sample size is described for the evaluation of the device's performance against specific acceptance criteria. The basis for equivalence relies on material comparison and biocompatibility testing. The data provenance (country, retrospective/prospective) is also not applicable as a clinical study is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable / Not Provided.
No clinical test set requiring expert ground truth establishment is described in this document.
4. Adjudication Method for the Test Set
Not Applicable / Not Provided.
Since no clinical test set is described, an adjudication method is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not Applicable / Not Provided.
This document does not describe an MRMC comparative effectiveness study. The evaluation focuses on material properties and intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable / Not Provided.
This is a medical device (root canal sealer/filler), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant.
7. The Type of Ground Truth Used
Not Applicable / Not Provided.
As no clinical study with a test set is detailed, there's no mention of expert consensus, pathology, or outcomes data as ground truth. The primary "truth" being established is substantial equivalence through chemical/physical property comparison and biocompatibility testing.
8. The Sample Size for the Training Set
Not Applicable / Not Provided.
This refers to an AI/machine learning context, which is not relevant for this medical device submission.
9. How the Ground Truth for the Training Set Was Established
Not Applicable / Not Provided.
This refers to an AI/machine learning context, which is not relevant for this medical device submission.
Summary of Study (as described in the document for FDA clearance):
The "study" described is a demonstration of substantial equivalence to a predicate device (EndoREZ Dual Cure, K042756).
- Brief Description of Testing Performed: "Each lot of product must pass internal test specifications prior to release. The results of biocompatibility testing demonstrate that the EndoREZ Dual Cure used with the EndoREZ Accelerator is compatible with its intended use as a root canal filler/sealer."
- Conclusion: The device (EndoREZ Dual Cure with Accelerator) is substantially equivalent to the predicate device. This conclusion is based on:
- Shared intended use (root canal sealer/filler)
- Similar material type (UDMA resin, methacrylate-based)
- Similar type of cure (Dual Cure)
- Similar characteristics (hydrophilic, radiopaque)
- Similar human factors (mixed, two-part system in double syringe)
- Similar biocompatibility/safety (literature and testing)
- The Accelerator's components include elements already in the Dual Cure and a commonly used accelerant in dental resins.
- No specific clinical performance study with defined endpoints, sample sizes, or statistical significance is detailed in this 510(k) summary.
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MAY 8 2007
Image /page/0/Picture/3 description: The image contains a sequence of characters that appear to be handwritten. The characters include 'K071106', with some of the characters being more clearly defined than others. The overall impression is that of a handwritten code or identifier.
SPECIAL 510(K) SUMMARY
EndoREZ® Dual Cure with Accelerator
This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for EndoREZ Dual Cure with Accelerator.
Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
| Contact Person: | Corey Jaseph |
|---|---|
| Title: | Regulatory Affairs Product Specialist |
| Telephone: | 800-552-5512 x4586, 801-553-4586 |
| FAX: | 801-553-4609 |
| Date Summary Prepared: | April 20, 2007 |
Name of the Device
| Trade Name: | EndoREZ Dual Cure with Accelerator |
|---|---|
| Common Name: | Resin, Root Canal Filling |
| Device Classification: | 2 |
| Classification Product Code: | KIF |
Legally Marketed Predicate Devices to Which Equivalence is Claimed
The predicate device is EndoREZ Dual Cure (K992097 and K042756). This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095.
Product Description
A unique biocompatible methacrylate-based root canal sealer/filler, EndoREZ is a two part, mixed, dual cure material with optional EndoREZ Accelerator included. EndoREZ has hydrophilic characteristics providing excellent penetration into dentinal tubules. This allows for improved sealing properties combined with ease of placement and removal. Radiopacity equivalent to gutta percha simplifies radiographic interpretation. EndoREZ does not compromise the function of dentin bonding agents or luting resin polymerization.
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Indications for Use
EndoREZ is designed to be used with EndoREZ Points and/or gutta percha for the filling of cleaned and shaped root canals. EndoREZ, in conjunction with a master cone and accessory cones (as needed), provides optimum sealing. Although EndoREZ Points are recommended, EndoREZ may be used with all conventional endodontic obturation techniques.
Table 1: Product Comparison
| Property | EndoREZ Dual Cure with Accelerator | Predicate: EndoREZ Dual Cure (K042756) |
|---|---|---|
| Intended Use | Root canal sealer/filler | Same |
| Type of material | UDMA resin | Same |
| Type of cure | Dual Cure | Same |
| Characteristics | Hydrophilic and radiopaque | Same |
| Human factors | Mixed, two-part system in a double syringe | Same |
| Biocompatibility/Safety | Literature and testing demonstrate product is safe when used as directed | Same |
Technological Characteristics
EndoREZ Dual Cure is a methacrylate-based root canal sealer/filler consisting of a twopart, mixed, dual-cure, radiopaque material with hydrophilic characteristics that allow for penetration into dentinal tubules. The formulation of the base and catalyst of the Dual Cure are the substantially the same as in K042756.
An accelerant is being added to the obturation kit and is also available separately that may be used in conjunction with the EndoREZ Dual Cure. The Accelerator will be provided in a unit dose vial (35 µL per vial) for use with EndoREZ Points (or, alternatively, gutta percha). The points (or gutta percha) are dipped into the Accelerator then placed in the root canal. When the Dual Cure comes in contact with the dipped points, the curing reaction is accelerated from 12 - 20 minutes to 4 - 6 minutes.
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The Accelerator is comprised of three proprietary elements. Two of the elements are also components of the Dual Cure (a monomer and an inhibitor). The third element is commonly used as an accelerant in polymerization reactions in dental resin fillings and bone cements.
Brief Description of Testing Performed
Each lot of product must pass internal test specifications prior to release. The results of biocompatibility testing demonstrate that the EndoREZ Dual Cure used with the EndoREZ Accelerator is compatible with its intended use as a root canal filler/sealer.
Conclusion and Substantial Equivalence
In conclusion, the EndoREZ Dual Cure used with the EndoREZ Accelerator, to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200 South, South Jordan, UT 84095, is substantially equivalent to the EndoREZ Dual Cure used alone, also manufactured by Ultradent Products, Inc. The two products are composed of nearly the same materials, have the same intended use and technological characteristics, and both are safe and effective when used for the indications described.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing the bird's body and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 8 2007
Ms. Corey Jaseph Regulatory Affairs Product Specialist Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re: K071106
Trade/Device Name: EndoREZ Dual Cure with Accelerator Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: April 18, 2007 Received: April 23, 2007
Dear Ms. Jaseph:
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 - Ms. Jaseph
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" (21CFR 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,
Susan Runer
Chiu Lin, Ph.D. 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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STATEMENT OF INDICATIONS FOR USE
071106 510(k) Number (if known):
Device Name: ___ EndoREZ Dual Cure with Accelerator
Indications for Use:
EndoREZ is designed to be used with EndoREZ Points and/or gutta percha for the filling of cleaned and shaped root canals. EndoREZ, in conjunction with a master cone and accessory cones (as needed), provides optimum sealing. Although EndoREZ Points are recommended, EndoREZ may be used with all conventional endodontic obturation techniques.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
ion of Anaesthesiology, General Hospital,
ion Control, Dental Devices
k) Number:
Page 1 of 1
(Posted November 13, 2003)
§ 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.