(106 days)
saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
saremco print CROWNTEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.
The provided document does not contain information related to an AI/ML device or a multi-reader, multi-case (MRMC) study. The device, "saremco print CROWNTEC," is a light-curing 3D-printed material for dental restorations (e.g., crowns, inlays, veneers, artificial teeth).
The "study" described in the document is a non-clinical performance testing and biocompatibility evaluation of this dental material, specifically to demonstrate its substantial equivalence to predicate devices for FDA 510(k) clearance.
Therefore, I cannot provide answers to the requested information about acceptance criteria, study details, expert involvement, or AI/ML performance metrics, as these are not relevant to the described device and its evaluation process.
Instead, the document details the following:
- Acceptance Criteria (inferred from testing): The device (material) was tested and met the applicable requirements of the following ISO standards:
- ISO 4049:2019 - Dentistry - Polymer-based restorative materials
- ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials
- ISO 22112:2017 – Dentistry – Artificial teeth for dental prostheses
- ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- ISO 7405:2018 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
- Reported Device Performance:
- Flexural Strength: Average ≥ 135 MPa (compared to predicate devices ranging from > 50 MPa to 148.73 MPa).
- Study Type: Non-clinical bench testing and biocompatibility assessment.
- Ground Truth: The "ground truth" in this context refers to the established requirements and performance metrics defined by the aforementioned ISO standards, against which the material's properties were measured.
- Clinical Performance Data: The document explicitly states, "No human clinical testing was performed to support the substantial equivalence of saremco print CROWNTEC."
- Training Set/Test Set (as per ML context): Not applicable, as this is a material science characterization, not an AI/ML model development.
- Data Provenance: The tests were conducted by the manufacturer (Saremco Dental AG). Data provenance for the material properties would be from the laboratory tests.
- Experts and Adjudication: Not applicable in the context of an AI/ML study, but the ISO standards represent a consensus of expert knowledge in dental material science.
§ 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.