Search Results

This product is indicated for the manufacturing of bases of partial or full removable dentures, occlusal splints and night guards through heating and pneumatic injection of the material, following the Instructions of Use that come with the product.

FLEX FIT is a polyamide resin for non-clasp dentures. It is suitable for deep undercut cases, which need strength. The resin material has an inherent flexibility allowing for a strong yet flexible denture to be created. FLEX FIT (known as Bio Tone in attached test summaries) is a denture resin that is primarily based on polyamide. It is sold as a clear or pink colored, fine granular resin that is 1~2 mm3 in diameter. The resin is packaged in a re-sealable plastic containers. Using an injection-molding method, FLEX FIT polyamide resin can be effectively used to make various types of dentures that retain the highly flexible, yet durable characteristics. It is a highly effective material for making non-clasp dentures, partial prosthetic dentures, dental plates, denture bases, bite plates, personal trays, night guards, splints, etc. It uses thermal polymerization as its mode of polymerization. The FLEX FIT offers two colors: clear and pink.

The provided document is a 510(k) Pre-Market Notification for a dental resin called "FLEX FIT." It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving the device meets those criteria.

Here's why and what's missing:

• Acceptance Criteria and Reported Performance: The document states that "Physical testing meets standard for dental base polymers ISO 20795 - yes" and "Biocompatibility ISO 10993 complied." These are high-level statements that the device meets certain standards, but they do not provide a table of specific numerical acceptance criteria (e.g., minimum flexural strength, maximum water sorption) and the reported device performance against those specific criteria.
• Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document mentions "Performance Tests in accordance with ISO 20795-1" and "Biocompatibility Tests in accordance with ISO 10993" with specific tests listed (Cell Toxicity, Sensitization, Oral Mucosal Stimulation, Acute Toxicity). However, these are general descriptions of types of tests. The document does not provide details about:
  • The sample size used for these tests.
  • The provenance of any data (e.g., if human subjects were involved, which they typically are not for material property testing).
  • The involvement of experts or an adjudication method, which are relevant for diagnostic devices that rely on interpretation, not for material property testing.
  • Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done (this is for diagnostic AI devices, not material property).
  • Whether a standalone (algorithm-only) performance was done (again, for AI/diagnostic devices).
  • The specific type of "ground truth" used beyond stating compliance with standards (e.g., "patrology" or "outcomes data" are not relevant here; the ground truth would be the defined specifications of the ISO standards).
  • The sample size for any training set or how ground truth was established for it (irrelevant for a dental resin where properties are measured directly against standards, not learned by an AI).

In summary, the provided document is a regulatory submission for a dental material (resin). It confirms that the material meets relevant ISO standards for physical properties and biocompatibility. The questions you've asked are typically relevant for diagnostic software algorithms or AI-driven medical devices that analyze images or patient data and require validation against a 'ground truth' established by experts. This document does not describe such a device or study.

Ask a specific question about this device

Nobilplast Denture Resin is intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night quards.

Nobilplast Denture Resin is a polyamide (nylon) resin available in pink and white colors. The resin granules are packaged in injectable aluminum cartridges or sold in a bulk container where users can fill empty aluminum cartridges that are sold separately.

The FDA 510(k) summary for Nobilplast Denture Resin is a submission for substantial equivalence based on comparison to legally marketed predicate devices. The document does not describe a clinical study in the typical sense (e.g., a multi-reader, multi-case study with human-in-the-loop performance or standalone algorithm performance). Instead, it relies on bench testing and a comparison of material properties and indications for use to existing predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, ground truth establishment, and expert involvement are not applicable in this context. The document focuses on demonstrating that the new device is as safe and effective as the predicate devices based on material characteristics and standard tests.

Here is an attempt to address the prompts based on the provided document, noting where information is not applicable (N/A) for this type of submission:

Acceptance Criteria and Device Performance for Nobilplast Denture Resin

The acceptance criteria for Nobilplast Denture Resin are implicitly based on demonstrating that its material properties and performance characteristics are substantially equivalent to its primary predicate device, FLEXSTAR V, and other reference devices (TCS Unbreakable, DENTSOLL Rezen NF, and Valplast). This is achieved through a series of bench tests and a comparison of intended use and material composition.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on direct comparison rather than a device with specific quantifiable "performance" in a diagnostic or assistive capacity, the acceptance criteria are framed as "similarity" or "comparability" to established predicate devices. The "reported device performance" is how Nobilplast Denture Resin's measured properties compare to those of the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a "sample size" in terms of cases or images for testing an AI device. Instead, it refers to the number of samples used for various bench tests of the material properties. These are standard material science tests, and the sample sizes would be defined by the specific ASTM/ISO standards referenced (e.g., a certain number of specimens for tensile strength, impact, etc.). The document does not provide these detailed sample counts.
• Data Provenance: The data provenance is from laboratory bench testing of the Nobilplast Denture Resin material, as well as biological testing. This is not clinical data derived from patients or images. It is prospective testing performed on the manufactured material. The country of origin for the data is not explicitly stated, but the company is based in the USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This is a material testing submission, not an AI or diagnostic device submission requiring expert human interpretation of data for ground truth. The "ground truth" here is the measured physical and chemical properties of the material, verified through standardized testing protocols (ASTM, ISO).

4. Adjudication Method for the Test Set

N/A. No human adjudication is involved for material properties testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This type of study is for diagnostic or assistive devices involving human readers interpreting cases. Nobilplast Denture Resin is a material for fabricating dentures.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Standardized Bench Testing: Direct measurement of material properties (e.g., density, melting point, hardness, tensile strength, flexural properties, impact strength, sorption & solubility) according to internationally recognized ASTM and ISO standards.
• Biocompatibility Testing: Evaluation of biological response as suggested by FDA Guidance (Cytotoxicity, Irritation, Sensitization tests).
• Comparison to Predicate Devices: The established and legally marketed performance and safety profiles of the predicate devices (FLEXSTAR V, TCS Unbreakable, DENTSOLL Rezen NF, Valplast) serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

N/A. There is no training set as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable.

Ask a specific question about this device