(69 days)
Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-cured resin indicated for the fabrication of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges.
Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-curing, hybrid dental material, composed of methacrylic acid esters, inorganic filler, photoinitiator, organic pigments, inorganic pigments and additives. It is Liquid resin for dental 3D printing of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of temporary or permanent dental restorations. For use in Digital Light Processing (DLP)- 3D printers utilizing wavelengths at 385nm or 405nm.
The Subject device is packaged in black plastic bottles made of high density polyethylene (HDPE) according to the weight of the resin liquid.
There are different shades A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, BL1, BL2, BL3, BL4, and the different shades are reflected in the different colors of finished restorations.
The provided FDA 510(k) clearance letter and summary describe a dental resin, not an AI/software as a medical device (SaMD). Therefore, the information required for explaining AI/SaMD acceptance criteria and studies (such as diagnostic performance metrics, reader studies, ground truth establishment, training/test set details, etc.) is not present in this document.
The document focuses on the physical, mechanical, and biocompatibility properties of a dental manufacturing resin. As such, I cannot extract the requested information regarding AI/SaMD performance studies from this provided text.
Here's a breakdown of why the requested information cannot be provided based on the input:
- Device Type: The device, "Additive Manufacturing (Light Curing) Crown Bridge Resin," is a material used for 3D printing dental restorations. It is not an AI algorithm or software.
- Study Type: The studies performed are bench tests (
Non-clinical Test Conclusion) evaluating material properties (e.g., flexural strength, water sorption, biocompatibility) against established ISO standards, and shelf-life testing. These are not studies to prove the performance of an AI model. - Acceptance Criteria & Performance: The acceptance criteria are explicitly tied to physical and mechanical properties (e.g., Flexural Strength ≥ 50 MPa as per ISO 10477:2020), not diagnostic accuracy or other AI-related metrics.
- Missing Information Related to AI/SaMD: All specific points requested in your prompt (sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, effect size) are entirely absent because they are not applicable to the clearance of a dental resin material.
In summary, the provided document does not contain the information necessary to describe the acceptance criteria and study that proves an AI/SaMD device meets its acceptance criteria. The document pertains to a physical dental material, not an artificial intelligence product.
§ 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.