DURAFLEX

• K Number: K063626
• Device Name: DURAFLEX
• Manufacturer: COSMETIC DENTAL MATERIALS INC
• Date Cleared: 2007-02-08 ( 64 days)
• Product Code: EBI
• Regulation Number: 872.3760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The DuraFlex thermoplastic resin is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

Device Description

The DuraFlex material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.

AI/ML Overview

This document is a 510(k) Premarket Notification for a dental resin called DuraFlex. The content describes the device, its intended use, and argues for its substantial equivalence to a predicate device, Lucitone FRS Flexible Dental Resin.

Here's an analysis of the provided information regarding acceptance criteria and studies:

Assessment:

Based on the provided document, the device described, DuraFlex, is a thermoplastic resin used in dentistry. The submission is a 510(k) Premarket Notification which, by its nature, demonstrates substantial equivalence to a previously legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies.

Therefore, the requested information about acceptance criteria, device performance tables, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set details are not applicable to this type of submission.

Explanation regarding 510(k) Substantial Equivalence:

A 510(k) submission does not typically involve clinical trials or performance studies to establish new safety and effectiveness. Instead, it aims to demonstrate that a new device is "substantially equivalent" to a predicate device that is already legally marketed in the U.S. This means the new device is as safe and effective as the predicate device, or it has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as a legally marketed predicate device.

The "study" described in this document is primarily a comparison of technological characteristics between DuraFlex and Lucitone FRS Flexible Dental Resin.

Specific answers to your questions based on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Not applicable. This document does not present acceptance criteria for performance or a table of reported device performance in the way a clinical study would. The focus is on demonstrating substantial equivalence to a predicate device. The performance is implied to be equivalent to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable. No test set data or clinical study data is presented in this document. The "study" is a comparison of material properties and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. No ground truth establishment by experts is described as there is no test set or clinical study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No test set or adjudication method is described.

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:

   • Not applicable. This device is a dental resin, not an AI-powered diagnostic tool. MRMC studies are irrelevant in this context.

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

   • Not applicable. This is a material science product, not an algorithm.

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

   • Not applicable. No ground truth in the context of clinical performance is established or used for this submission. The "ground truth" for substantial equivalence is the known characteristics and safety record of the predicate device.

8. The sample size for the training set:

   • Not applicable. This is a material, not a machine learning algorithm. There is no training set mentioned or implied.

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

   • Not applicable. There is no training set described.

In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical dental material (resin), not a clinical study to establish new performance metrics for a diagnostic or AI-driven device.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.