(240 days)
- Fabrication of temporary crowns, bridges, inlays, onlays and veneers
- Fabrication of long-term temporary restorations
GC Temp PRINT is 3D printable light curing composite for temporary crown and bridge. The device consists of a paste delivered in a bottle. GC Temp PRINT is fabricated with certain Digital Light Processing/Stereolithography Apparatus (DLP/SLA)a` 3D printers and post cured with light curing device into dental restorations, which are then bonded to tooth structure with adhesive temporary cement.
The provided text is a 510(k) summary for a dental device called "GC Temp PRINT". This document primarily focuses on establishing substantial equivalence to predicate devices, rather than describing a study proving the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, the requested information regarding acceptance criteria and performance study for AI/ML aspects cannot be fully provided from the given document as it refers to material properties and biocompatibility, not AI/ML performance.
However, I can extract the acceptance criteria and the bench test results for the physical properties of the GC Temp PRINT device as described in Section 6, "Performance Bench Tests".
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Standards | Acceptance Criteria (Requirements in ISO 10477:2018 and/or Company specification) | Reported Device Performance (Implied "Compliance") |
|---|---|---|---|
| Depth of cure | Company specification (1AB-1500-3-10696(3)) | 0.098 – 0.130 mm | Complies |
| Flexural strength | ISO 10477: 2018 5.4 Flexural strength (Fabricated by 3D Printer) | > 50 MPa | Complies |
| Water sorption | ISO 10477: 2018 5.6 Water sorption (Fabricated by 3D Printer) |
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.