(203 days)
Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
Glidewell™ 3DP Denture Base Resin is a light-cured resin for the fabrication of removable 3DP denture bases, including full and partial dentures, fabricated in a professional dental setting. The resin is compatible with DLP printers utilizing wavelengths of 405nm and is offered in G1 (standard pink), G3 (medium pink) and G4 (dark pink) shades formulated to match gingival tissue.
Here's a breakdown of the acceptance criteria and the study information for the Glidewell™ 3DP Denture Base Resin, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from ISO 20795-1: 2013 for Type 4 Light-activated materials) | Reported Device Performance (Glidewell™ 3DP Denture Base Resin) | P-value/Statistical Significance (if available) |
|---|---|---|---|
| Flexural Strength | > 65 MPa | > 65 MPa | Not specified |
| Flexural Modulus | > 2000 MPa | > 2000 MPa | Not specified |
| Water Sorption |
§ 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.