(87 days)
Pekkton® ivory is intended to be used for long-term, temporary dental crowns and bridges frameworks.
Pekkton® ivory is a semi-crystalline thermoplastic supplied in blanks. Pressing the blank gives a framework, from which the dental technician manufactures the final veneered dental crown and / or temporary dental bridge.
This document describes the premarket notification for the Pekkton® ivory dental device. The information provided focuses on demonstrating substantial equivalence to predicate devices and verifying the biological safety and performance of the device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, summarized format. However, it lists several biological evaluation tests and states that the "acceptance criteria were met."
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Tests: | ||
| Cytotoxicity (EN ISO 10993-5) | No cytotoxic potential | Meets requirements: Investigated material Pekkton® ivory can be evaluated to have no cytotoxic potential. |
| Irritation (EN ISO 10993-10) | Acceptable | Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety. |
| Delayed Type Hypersensitivity (EN ISO 10993-10) | Acceptable | Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety. |
| Acute Systemic Toxicity (EN ISO 10993-11) | Acceptable | Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety. |
| Subchronic and chronic systemic toxicity (EN ISO 10993-11) | Acceptable | Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety. |
| Implantation (EN ISO 10993-6) | Acceptable | Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety. |
| Genotoxicity (EN ISO 10993-3) | No genotoxic potential | Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety. |
| Carcinogenicity (EN ISO 10993-3) | No carcinogenic potential | Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety. |
| Chemical characterization (EN ISO 10993-18) | No potentially organic toxic leachable substances | Meets requirements: None of the investigated extracts exhibited any product-related peaks, indicating no potentially organic toxic leachable substances were released. |
| USP Plastic Class VI | Meets USP 34 (88) requirements | Meets requirements: Systemic injection tests exhibited no adverse clinical signs. Concluded that the test material Pekkton® ivory meets the requirements of the USP Plastic Class VI. |
| Physical/Mechanical Tests: | ||
| Chemical and physical properties | According to material data sheet (Predicate benchmarks) | Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices. |
| Bond strength to veneering composites | Acceptable levels | Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices. |
| Static fracture load | Acceptable levels | Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices. |
| Fatigue tests | Acceptable levels | Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices. |
| Simulated use tests | Acceptable performance | Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes for each test in the test set. It mentions that the studies were performed "in compliance with international GLP regulations," which implies controlled laboratory settings. The data provenance is from Cendres+Métaux SA, Switzerland, and the testing was retrospective (meaning conducted specifically for the 510(k) submission, not as part of an ongoing clinical trial).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. The testing described is primarily laboratory-based (biocompatibility, chemical, physical) rather than relying on human expert interpretation for ground truth.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable/provided. The tests are objective laboratory measurements, not reliant on expert adjudication of results.
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
This information is not applicable/provided. The device is a dental material (Pekkton® ivory) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/provided. The device is a material, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the test set was established through standardized laboratory testing protocols and established scientific methods, as defined by international standards (e.g., ISO 10993 series, USP 34 ) for biocompatibility, and material science methodologies for chemical and physical properties. For example:
- Biocompatibility: The "ground truth" for cytotoxicity was the observable impact on L929 mouse fibroblasts. For chemical characterization, it was the absence of product-related peaks in GG/MS / ICP analyses.
- Physical/Mechanical Properties: The "ground truth" was based on quantitative measurements (e.g., bond strength, fracture load, fatigue) compared against benchmarks from predicate devices or established material data sheets.
8. The Sample Size for the Training Set
This information is not applicable/provided. The submission describes a device validation through physical and biological testing, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided as there is no training set for a machine learning model.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.