(195 days)
VITA VIONIC® Bond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.
VITA VIONIC® Bond is a two-component glue, mainly composed of acrylate polymers based on methyl methacrylate and used to fix artificial teeth in the milled denture base. VITA VIONIC® component I comes in a glass jar with a screw top lid and VITA VIONIC® Bond component II comes in a glass bottle with a screw top cap. Component II is mixed into component I by stirring until no streaks are visible. A thin film is then applied to all Bonding surfaces and then the artificial teeth are placed into the denture base and VITA VIONIC® Bond is allowed to cure. Comes in one, colorless shade. This product is provided non-sterile.
This document describes the non-clinical performance testing for VITA VIONIC® Bond, a two-component glue for fixing artificial teeth.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard & Section) | Reported Device Performance |
|---|---|
| DIN EN ISO 20795-1:2013 - Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2013) | The device was evaluated according to this standard. Specifically, the device was tested under section 8.7 "Bonding to synthetic polymer teeth" and section 8.9: Water solubility and water sorption. The bench test results allowed the manufacturer to conclude that VITA VIONIC® Bond is substantially equivalent to the predicate device for its intended use. (Specific numerical performance values are not provided in this summary.) |
| ISO 10993-1:2009 - Biological evaluation of medical devices | Biocompatibility assessment performed. Tests conducted for cytotoxicity, sensitization, irritation and intracutaneous reactivity, and genotoxicity. Results showed no cytotoxic or genotoxic results, and irritation and sensitization risks were evaluated as low. This assessment supports the biocompatibility of the device. |
| ISO 7405:2004 (or 2008 as cited in Biocompatibility section) – Dentistry – Evaluation of biocompatibility of medical devices | (Same as ISO 10993-1:2009) Biocompatibility assessment performed. Tests conducted for cytotoxicity, sensitization, irritation and intracutaneous reactivity, and genotoxicity. Results showed no cytotoxic or genotoxic results, and irritation and sensitization risks were evaluated as low. This assessment supports the biocompatibility of the device. |
| Chemical Analysis (Residual monomer content) | Residual monomer content was found to be below the limit values. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The document refers to "bench test results" and "biocompatibility tests."
- Data Provenance: The testing was conducted by or on behalf of VITA Zahnfabrik H. Rauter GmbH Co. which is located in Germany. These are non-clinical (bench and lab) studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable as the described testing is non-clinical performance evaluation, not expert-based assessment of clinical images or data. The "ground truth" for these tests are the established scientific and engineering principles and specifications defined by the respective ISO/DIN standards.
4. Adjudication Method for the Test Set
- This information is not applicable for non-clinical performance tests. Outcomes are typically based on objective measurements against predefined criteria/limits outlined in the standards.
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. This submission pertains to a physical dental bonding agent, not an AI-powered diagnostic device or software. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This submission pertains to a physical dental bonding agent, not an algorithm or AI.
7. The Type of Ground Truth Used
- For the non-clinical performance testing (e.g., bonding strength, water absorption/solubility, residual monomer content), the ground truth is established by the specifications and methodology defined in the referenced international standards (DIN EN ISO 20795-1) and chemical analysis techniques.
- For biocompatibility, the ground truth is established by the results of in vitro and in vivo (pre-clinical) biological tests performed according to ISO 10993-1 and ISO 7405, which assess endpoints like cytotoxicity, genotoxicity, irritation, and sensitization against accepted safety thresholds.
8. The Sample Size for the Training Set
- This information is not applicable. This submission pertains to a physical dental bonding agent. There is no "training set" in the context of machine learning for this device.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable. As there is no training set, there is no ground truth for a training set.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.