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Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM. Indications:

• Temporary anterior and posterior crowns
• Temporary anterior and posterior bridges with up to two adjacent pontics
• Implant supported temporary restorations

Maximum recommended usage period: 12 months

• Removable structures for dentures (dental bases)
• Removable structures for therapeutic restorations (bite splints or occlusal splints)

Dental polymer blank is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a Cad-controlled milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blanks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.

Dental polymer blanks are made with the same material (Hot cured PMMA) that is used for the manufacture of the Union Dental artificial teeth brands ODILUX and ODIPAL (K070591). These polymer discs or blocks are especially suited for creating dental structures by means of milling CAD/CAM techniques commonly used in the dental laboratories and in dental practice. The elaboration is designed by a professional, a dental technician or a dentist. This quarantees their correct use, since it is an intermediate product in order to manufacture a custom-made product.

The provided document describes the FDA 510(k) summary for a dental polymer blank device named IDODENTINE. It details the device's characteristics, intended use, and a comparison with predicate devices to establish substantial equivalence based on non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

Key Takeaway: This document does not describe a study comparing the performance of the IDODENTINE device against acceptance criteria in the way a diagnostic or AI device would be evaluated. Instead, it demonstrates substantial equivalence to predicate devices based on meeting established ISO standards for dental materials and biocompatibility through non-clinical physical and chemical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are the requirements specified by the relevant ISO standards (ISO 10477, ISO 20795, ISO 22112, ISO 10993-5) for polymer-based dental materials. The device's performance is demonstrated to meet or exceed these requirements and be comparable to the predicate device.

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

The document does not specify a "test set" in the context of a diagnostic or AI study with patient data. The testing performed is non-clinical, involving material properties.

• Sample size for non-clinical tests: Not explicitly stated as a number of distinct material samples, but rather implies that the material was tested according to ISO standard methodologies.
• Data provenance: The data comes from internal testing by the manufacturer (Union Dental S.A.) and external reports from NIOM (Nordic Institute of Dental Materials) and Innovatech. This is prospective testing of the manufactured material. The country of origin for the device is Spain, and for the external testing labs, NIOM is located in Norway, and Innovatech is not specified but is a testing service.

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

N/A. This is a non-clinical material performance evaluation, not a study requiring expert readers or ground truth established by medical professionals. The "ground truth" is the established international standard (ISO) for material properties.

4. Adjudication Method

N/A. Not applicable for non-clinical material testing.

5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study

N/A. This is a non-clinical material performance evaluation, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

N/A. This is a material, not an algorithm or AI device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is represented by the requirements specified in the international ISO standards (ISO 10477, ISO 20795, ISO 22112 for material properties, and ISO 10993-5 for biocompatibility). These standards define the acceptable range or minimum/maximum values for specific physical, chemical, and biological properties of the dental material.

8. Sample Size for the Training Set

N/A. This document does not describe a training set as it pertains to an AI or machine learning model. The device is a fabricated material, not a software algorithm.

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

N/A. Not applicable as there is no training set mentioned in the context of an AI/ML algorithm.

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Teeth for the fabrication of dentures These teeth are used for making full or partial dentures. The These toon are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patients mouth and is a removable. It is not implanted.

A preformed plastic denture tooth is a prefabricated device, composed of Polymethyl Methacrylate. The teeth are made up of several different acrylic resins that form the layers of enamel, dentine and neck, all of which are created using the polymerization of acrylic monomers, reticulant agents, resins and non-toxic pigments that form a unique composition, which with the union of the layers produces a compact whole that looks and behaves in a similar wav to real teeth. Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them. They are then mounted in the presentation units with the relevant product details (brand, model, colour and batch).

The provided text describes a 510(k) summary for preformed plastic denture teeth. This type of submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

However, based on the information provided, I can infer the "acceptance criteria" through the standards the device was tested against and the performance indicated by achieving substantial equivalence.

Here's an analysis of the "acceptance criteria" and the "study" based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a bench testing and regulatory submission process rather than a traditional in-depth study designed to establish acceptance criteria and prove performance against them in a statistical manner. The "study" here refers to the process of gathering evidence for regulatory approval.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The performance testing refers to adherence to ISO and ADA standards, which typically involve testing representative samples of the product. The exact number of teeth tested or the batch sizes are not provided.
   • Data Provenance: Not explicitly stated, but the testing would have been conducted by the manufacturer, Union Dental S.A./ Unidesa, in Spain, as per their address. It would be considered bench testing (laboratory-based), not clinical data (retrospective or prospective).

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable in the context of this 510(k) submission. The "ground truth" for the performance claims relies on compliance with established international and American dental standards (ISO 3336:1993 and ADA Specification No. 15:1999) and biocompatibility testing. These standards define the acceptable performance characteristics, and the "experts" would be the scientists and engineers conducting those tests according to the specified protocols, and the standards bodies themselves.

3. Adjudication Method for the Test Set:

   • Not applicable. Performance is assessed against defined parameters in the ISO/ADA standards, not typically through expert adjudication of individual test results in the way a clinical study might.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, a MRMC comparative effectiveness study was not done. This is a preformed plastic denture tooth, and such studies are typically for diagnostic imaging devices where human reader performance is a key metric.

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

   • Not applicable. This is not an AI/algorithm-based device.

6. The Type of Ground Truth Used:

   • The "ground truth" for the device's performance claims is based on established industry standards (ISO 3336:1993, ADA Specification No. 15:1999) for synthetic polymer teeth and biocompatibility guidelines (Directive 93/42/EEC, Annex X). This means the device's physical, chemical, and biological properties are compared to the benchmarks set by these recognized consensus standards.

7. The Sample Size for the Training Set:

   • Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no training set.

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