(306 days)
- Definitive supported and veneered crowns and bridges with maximum two pontics. Can be veneered with bonded press crowns, with composites or prefabricated acrylic teeth and veneers.
- Definitive supported, veneered single crowns and bridges with maximum one pontic on natural teeth.
- Removable restoration such as secondary structures on bars and telescopic crowns, transversal connectors, occlusal splints and denture bases.
Pekkton® Ivory is a semi-crystalline thermoplastic supplied in milling blanks and press blanks. By application of CAD/CAM milling or pressing technology according to the instructions for use, it can be used by the dental technician to manufacture permanent crowns, bridges and denture frameworks.
This document is a 510(k) premarket notification for a dental material called Pekkton® Ivory. It does not describe an AI/ML powered device, but rather a physical dental product. Therefore, the information requested about acceptance criteria and study proving the device meets the criteria, particularly regarding AI/ML specifics like MRMC studies, training/test sets, and expert adjudication, is not applicable to this document.
The document discusses the substantial equivalence of Pekkton® Ivory to a predicate device (BioHPP-breCAM.BioHPP) and a reference device (Pekkton® Ivory K123638). The "studies" mentioned are primarily non-clinical tests to assess biological, chemical, and physical properties of the material.
Here's an analysis of what is provided, framed as closely as possible to your request, but acknowledging the difference in device type:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparative table of technological characteristics between the predicate device (BioHPP-breCAM.BioHPP) and Pekkton® Ivory, along with relevant standards. These values serve as the "performance" data, and the comparison to the predicate and relevant ISO standards imply the "acceptance criteria."
| Characteristic | Predicate Device (BioHPP-breCAM.BioHPP) | Pekkton® Ivory (Candidate) | Remarks / Implied Acceptance Criteria |
|---|---|---|---|
| Device Name | BioHPP- breCAM.BioHPP | Pekkton® Ivory | Comparable device type |
| 510(k) No | K152113 | K170102 | (Not a performance metric) |
| Classification Name | Tooth shade resin material | Tooth shade resin material | Same classification name |
| Product Code | EBF | EBF | Same code |
| Regulation Number | 872.3690 | 872.3690 | Same regulation |
| Intended Use | Fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. | Intended for use with fixed (crowns and bridges) and removable dental prostheses. | Comparable intended use |
| Material | PEEK (Polyetheretherketone) | PEKK (Polyetherketoneketone) Titanium Dioxide | Both are Poly-aryl-ether-ketones (PAEK), considered comparable. |
| Form | Granulate-Pellets, Disc | Press blanks, Milling blanks | Comparable forms |
| Processing | Melt processing of thermoplastic (Heat and pressure) | CAD/CAM Milling, Melt processing of thermoplastic (Heat and pressure) | Comparable processing |
| Melting Temperature | approx. 340°C | Approx. 363 °C | Comparable temperature |
| Bond strength to veneering resins | 25.2 MPa | > 15 MPa | Standard ISO EN 10477:2004 requires 5 MPa. Pekkton® Ivory exceeds this. |
| E-Modulus | approx. 4083 – 4630 MPa | approx. 5000 MPa | Compared against ASTM-D638. Value is within a comparable range. |
| Flexural strength | 163 – 179 MPa | 200 MPa | Compared against ASTM-D790. Value is within a comparable range. |
| Water absorption | 6.5 ug/mm3 | 8.7 ug/mm3 | Standard ISO 4049-2009 requires water sorption lower than 40 ug/mm3. Pekkton® Ivory meets this. |
| Water solubility | 0.1 ug/mm3 | 0.2 ug/mm3 | Standard ISO 4049-2009 requires water solubility lower than 7.5 ug/mm3. Pekkton® Ivory meets this. |
Acceptance Criteria Statement: The document explicitly states: "Testing has shown that Pekkton® Ivory is equivalent in performance characteristics to the predicate device BioHPP. The acceptance criteria were met."
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each physical/chemical test (e.g., how many specimens were tested for flexural strength). It refers to "non-clinical test data."
- Data Provenance: The tests were conducted according to international standards (ISO, USP, ASTM). The country of origin of the data is implied to be Switzerland, where CENDRES+METAUX SA is based. The data is "retrospective" in the sense that the testing was completed prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for a physical dental material is established through objective, standardized physical and chemical tests, not through expert consensus on interpretations like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective assessments, typically in image interpretation or clinical outcomes, not for objective material property testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is for a physical dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on objective, quantitative measurements of physical and chemical properties (e.g., melting temperature, bond strength, flexural strength, water absorption/solubility) derived from adherence to established international standards (ISO, ASTM, USP).
- For biological risks, the "ground truth" or assessment of safety is based on biocompatibility testing against recognized standards (ISO 10993 series and ISO 7405).
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for physical material properties in this context, as there is no machine learning model involved. The manufacturing process and material formulation are "trained" through R&D and quality control, but not in the AI/ML sense.
9. How the ground truth for the training set was established:
- Not applicable. See point 8. The "ground truth" for the material's properties is established through the test methods and standards mentioned in point 7.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.