(71 days)
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
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Chemical Composition: Comparable to predicate devices. | The device has comparable chemical composition to the predicate devices. |
| Physical Characteristics: Similar in size, shape, color, and usage to predicate devices. | The device is similar in size, shape, color, and usage as the above predicates devices. |
| Biocompatibility: Meets standards for contact with the human body (implied by biocompatibility tests and 93/42/EEC Annex X). | Biocompatibility tests performed. |
| Durability/Mechanical Properties: Complies with ISO 3336:1993 (Dentistry-Synthetic Polymer Teeth) and ADA Specification No. 15:1999 (Synthetic Resin Teeth). | Device tested according to ISO 3336:1993, which is similar to ISO ADA Specification No. 15:1999. |
| Labeling Requirements: Includes proprietary name, shade comparable to competitors, and a mold number. | The labeling includes the proprietary name, the shade (comparable to competitors), and a mold number. |
| Safety and Effectiveness: Confirmed to be safe and effective for its intended use as denture teeth. | Concluded to be safe and effective to be used as denture teeth. |
| Substantial Equivalence: Demonstrated to be substantially equivalent to legally marketed predicate devices. | Determined to be substantially equivalent to legally marketed predicate devices. |
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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set.
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.