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510(k) Data Aggregation
(176 days)
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
| Physical/Biocompatibility Parameters | ISO 10477 / ISO 20795 Requirements (Acceptance Criteria) | Predicate Device Reported Performance | IDODENTINE Reported Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993 | ISO 10993-5 Non cytotoxic | ISO 10993-5 Non cytotoxic (NIOM test report 025/10) |
| Flexural strength | ≥ 50 MPa (ISO 10477), ≥ 65 MPa (ISO 20795) | 91.5 MPa | 90 MPa (NIOM test report 026/10) |
| Water absorption | ≤ 0.040 mg/mm³ (ISO 10477), ≤ 0.032 mg/mm³ (ISO 20795) | 0.026 mg/mm³ | 0.023 mg/mm³ (NIOM test report 026/10) |
| Water solubility | ≤ 0.007.5 mg/mm³ (ISO 10477), ≤ 0.001.6 mg/mm³ (ISO 20795) | 0.0002 mg/mm³ | 0.0000 mg/mm³ (NIOM test report 026/10) |
| Residual monomer content | ≤ 2.2% | 1% | 1.4% (Innovatech GC/MS test 115201-A) |
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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