(237 days)
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.
| Property | Acceptance Criteria (Implicit for Substantial Equivalence to Predicates) | Reported Nobilplast Denture Resin Performance |
|---|---|---|
| Intended Use | Must be substantially similar to predicate devices for fabrication of partial/full removable dentures, occlusal splints, and night guards. | Intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. (Minor differences from reference devices are explained as not practical for the material or application). |
| Type and Class | Must align with predicate devices (Type III, Class 1 denture material). | Type III, Class 1. |
| Chemical Family | Must be Polyamide, similar to predicate devices. | Polyamide. |
| CAS Number | Should be identical or closely related to the primary predicate (FLEXSTAR V: CAS# 25587-80-8). | CAS# 25587-80-8. |
| Material used to invest | Must be Dental Stone, similar to predicate devices. | Dental Stone. |
| Storage Temperature | Must be within a similar range to predicate devices (e.g., 60°F – 90°F). | 60°F – 90°F. |
| Dosage | Must be consistent (1 cartridge). | 1 cartridge. |
| Processing Time/Temperature | Must be comparable to predicate devices (e.g., primary predicate: 11 minutes @ 550°F (290°C)). | 11 minutes @ 550°F (290°C) (furnace heats one cartridge at a time). |
| Injection Time | Must be comparable to predicate devices (e.g., primary predicate: 3 minutes). | 3 minutes (using manual press). |
| Cool Time | Must be comparable to predicate devices (30 minutes). | 30 minutes. |
| Physical Properties | Must demonstrate expected properties (semi-flexible, rigid thick sections, flexible thin sections for clasps) consistent with the material type and intended use, similar to predicate devices. | Partial denture is semi-flexible: Thick sections are rigid to hold denture teeth into place while thinner areas, such as clasps, are slightly flexible to accommodate undercuts on abutment teeth. (Identical to description for FLEXSTAR V, DENTSOLL Rezen NF, and Valplast). |
| Bench Test Performance | Must meet standard industry specifications (ASTM, ISO) for material properties (Density, Melting Point, Hardness, Tensile, Flexural, Impact, Sorption & Solubility, DSC, TGA, Melt Flow Rate). | Subjected to various bench tests (Density per ASTM D792, Melting Point per ISO 11357, Hardness Shore per ISO 868, Tensile per ISO 527, Ultimate Flexural and Flexural Modulus per ISO 178, Charpy Impact ISO 179/1eU, Sorption & Solubility per ISO 20795, DSC Analysis per ASTM D3418, TGA Analysis per ASTM E1311, Melt Flow Rate Analysis, Izod Impact Strength per ISO 180 or ASTM D256). Specific numerical results are not provided in this summary but are implied to be within acceptable ranges to demonstrate equivalence. |
| Biocompatibility | Must demonstrate no biocompatibility issues. | Testing results indicate no biocompatibility issues exist for Nobilplast Denture Resin. |
| Shelf Life | Must demonstrate a reasonable shelf-life, comparable to predicate. | 5-year shelf-life demonstrated by real-time packaging study on the nearly identical product: FlexStar V. |
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.
§ 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.