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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.

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.

Ask a specific question about this device

EndoREZ is used for permanent obturation of root canals of teeth of the secondary dentition with or without the aid of obturation points. It is easily delivered to the canals with a small NaviTip. When mixed and delivered in a syringe, the sealer can be used for the single cone technique or for the continuous wave condensation technique.

Not Found

This is a Food and Drug Administration (FDA) 510(k) clearance letter for a dental device called EndoREZ, a root canal filling resin. The document states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain specific acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study information requested in your prompt (sample sizes, ground truth establishment, expert qualifications, etc.).

Therefore, I cannot provide the requested information about acceptance criteria and study details based on the provided text. The letter is purely an administrative clearance document.

Ask a specific question about this device

EndoREZ is used for permanent obturation of root canals of the secondary dentition with or without the use of obturation points. It is easily delivered to the root canal with a small Endo-Eze tip. When mixed and delivered, the material flows into the canal, eliminating or minimizing air entrapment.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA letter regarding the substantial equivalence of a medical device called "EndoRez Root Canal Sealer" and its indications for use. It's a regulatory approval document, not a scientific study report.

Ask a specific question about this device