(43 days)
- Bonding of direct composite, Polyglas® and compomer restorations .
- Bonding of indirect laboratory-fabricated ceramic, Polyglas and composite . restorations (inlays, onlays, veneers and crowns)
- 0 Treatment of hypersensitive tooth regions
iBond Total Etch is an improved light-component adhesive for use in adhesive restorative dentistry and was developed within the scope of the project IBTE on the base of an ethanol solution of light-activated, adhesive resins The material is characterized by the following properties in detail
- The material has been developed for the adhesive bonding of plastic filling materials (e g ♥ composites, comporner, Polyglas ) to dental hard substance and laboratory-fabricated restorations (e g ceramics)
- With IBOND Total Etch, priming, bonding and desensitizing can be done in one step .
- Before using IBOND Total Etch, the dental hard substance is conditioned with iBOND Etch 35 Gel (etch&rinse)
In its unpolymenzed state, the adhesive matenal is workable smilar to current products Cross linking reaction is initiated with light curing (QTH, LED) devices customary in dental technology Cross-Iniking of the methacrylate monomers occurs very fast, ensurng reliable curing of the adheswe layer
Thus, a highly cross-linked material results, fully complying with the mechanical requirements for a dental adhesive matenal
- Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or a dedicated performance table for iBOND Total Etch. Instead, it relies on comparative evaluations and conformity to established standards for dental materials.
| Acceptance Criteria Category | Description (as inferred) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets requirements of EN ISO 10993-1. | Confirmed to meet DIN EN ISO 10993 standard. Cured adhesive did not show significant toxicological reaction. Benefit/risk-relation judged as positive. |
| Physical Properties | Equal to or better than current Heraeus and competitive products. | Results have shown equal or better properties of iBOND Total Etch compared to current Heraeus and various competitive products. |
| Clinical Performance | Exhibits claimed technical performance; potential undesirable clinical effects and risks are well controlled and acceptable. Positive risk-benefit ratio. | Concluded that the product can be expected to exhibit claimed technical performance, and potential undesirable clinical effects and risks are well controlled and acceptable when weighed against benefits in dentistry. Positive risk versus benefit ratio stated by the expert. |
| Safety | Application considered safe (risk analysis according to EN ISO 14971). | Risk analysis carried out according to DIN EN ISO 14971 showed that the application of iBOND Total Etch could be considered safe. |
| Regulatory Compliance | Meets Medical Device Directive 93/42/EEC and national European medical device legislation. | Meets all requirements relevant for dental adhesive material in accordance with the Medical Device Directive 93/42/EEC and national European medical device legislation. Evaluated to be effective and safe. |
- Sample Size for Test Set and Data Provenance:
The document does not specify a sample size for any "test set" in the context of an algorithmic or AI-based device. This document describes a traditional medical device (dental adhesive) and its evaluation.
There is no data provenance information (country of origin, retrospective/prospective) for a "test set" as this type of study design is not applicable to the evaluation described.
- Number of Experts and Qualifications for Ground Truth:
The document mentions an "expert" for the clinical evaluation who states a positive risk-benefit ratio. However, it does not specify the number of experts used to establish ground truth or their specific qualifications (e.g., number of years of experience, specific medical specialty).
- Adjudication Method for Test Set:
An adjudication method is not applicable to the evaluation described in this document, as it is not an AI/algorithmic device requiring consensus on diagnostic labels from a test set.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not conducted as this is not an AI-assisted device. The document describes a dental adhesive material.
- Standalone (Algorithm Only) Performance Study:
A standalone performance study was not conducted as this is not an AI/algorithmic device.
- Type of Ground Truth Used:
The "ground truth" for this device's evaluation is primarily based on:
* Biocompatibility testing results against established international standards (DIN EN ISO 10993).
* Laboratory-measured physical properties of the material compared to established products.
* Clinical evaluation based on scientific data and technical results, assessed for safety and effectiveness in its intended use, likely drawing upon existing literature and expert judgment.
* Risk analysis outcomes according to DIN EN ISO 14971.
- Sample Size for Training Set:
The document does not mention a training set as this is not an AI/algorithmic device.
- How Ground Truth for Training Set Was Established:
This information is not applicable as there is no training set for an AI model. The evaluation of this device relies on standard medical device testing and clinical evaluation processes, not machine learning model training.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.