(301 days)
DIOnavi-Denture is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with DIOnavi-Denture requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.
DIOnavi-Denture is a photo-cured resin intended to fabricate full and partial removable dentures in a CAD/CAM additive printing process. The material is an alternative to traditional heat cured and auto polymerization resins. It is denture base resins, Photo-cured product family comprises a family of dimethacrylate resins. The dimethacrylate resin is polymerized via photo initiators in a 3D printer. The color of the denture is determined by the addition of pigments. The material is used in a 3D printer. which prints the shape determined by a 3D drawing. After printed product is placed in a UVlight curing box for final polymerization. 3D printer and UV-light curing box is not included with the device.
The denture fabrication process begins with a traditional impression or optical impression of the oral region in the dentist office. This impression is sent to a dental lab. The denture base is then made layer-bylayer in a DLP (digital light processing) printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.
The provided text is a 510(k) summary for the DIOnavi-Denture, a light-curable resin used for fabricating and repairing dentures. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through a clinical study. Therefore, several of the requested categories for acceptance criteria and study details are not directly applicable or available in this M.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to adherence to international standards and internal testing to demonstrate substantial equivalence, rather than defining specific clinical acceptance criteria for performance measures like diagnostic accuracy. The "acceptance criteria" are implied by meeting the requirements of the standards for similar devices.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (as per ISO 20795-1) |
|---|---|
| Visual Inspection (meets standard) | Results met criteria of the standard |
| Capacity (meets standard) | Results met criteria of the standard |
| Package Integrity (meets standard) | Results met criteria of the standard |
| Dimensions (meets standard) | Results met criteria of the standard |
| Surface Characteristics (meets standard) | Results met criteria of the standard |
| Shape Capability (meets standard) | Results met criteria of the standard |
| Translucency (meets standard) | Results met criteria of the standard |
| Color Stability (meets standard) | Results met criteria of the standard |
| Flexural Strength (after curing > 65 MPa as per predicate/reference) | DIOnavi-Denture: 65 65 MPa) |
| Density (within range of predicate/reference e.g., 1.05-1.3) | DIOnavi-Denture: 1.11-1.3 |
| Viscosity (within range of predicate/reference e.g., 770-2000 cPs) | DIOnavi-Denture: 770-1430 cPs |
| Biocompatibility (meets ISO 10993-1 requirements) | Cytotoxicity, Sensitization, Irritation reactivity, Genotoxicity, Sub-acute toxicity, Material-mediated pyrogenicity tests all addressed and met standards. |
| Shelf-life (2 years) | Shelf-life testing conducted with bench tests from ISO 20975-1, device has 2 years shelf-life. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not detail specific sample sizes for non-clinical performance tests. The testing was laboratory-based, not clinical, so direct provenance like "country of origin" or "retrospective/prospective" data in a clinical sense is not applicable. The tests performed were outlined to meet ISO standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This was a non-clinical, bench-testing study of material properties, not a study involving expert assessment or ground truth establishment based on human interpretation.
4. Adjudication Method for the Test Set
Not applicable. There was no element of human judgment or interpretation requiring adjudication.
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. The DIOnavi-Denture is a tangible dental material and not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or software device. The product is a resin for dental fabrication.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical testing was defined by the established criteria and physical/chemical measurement techniques specified in the relevant ISO standards (ISO 20795-1 for dental base polymers and ISO 10993 for biocompatibility). For example, flexural strength is measured directly rather than requiring expert consensus.
8. The Sample Size for the Training Set
Not applicable. This is a physical material, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no 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.