(138 days)
JUELLCure Soft is intended for use as a permanent soft relining for total and partial dentures
- . To relieve pressure from pressure points
- To dam the palatal vibrating line ●
- . In cases of flabby ridge and/or insufficient adhesion
- . To cushion sharp-edged alveolar processes
JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.
The provided text describes the 510(k) summary for the JUELLCure Soft device, which is a soft impression material for dentures. The submission aims to demonstrate substantial equivalence to a predicate device, Ufi Gel SC.
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for JUELLCure Soft are based on demonstrating equivalence to the predicate device, Ufi Gel SC, across chemical composition and key physical properties.
| Test Item | Acceptance Criteria (Equivalent to Ufi Gel SC) | JUELLCure Soft Performance |
|---|---|---|
| Monomer Matrix (Base) | 70-80 % | 70-80 % |
| Rheologic Modifier (Base) | 15-30 % | 15-30 % |
| Catalyst (Base) | 0.1-0.5 % | 0.1-0.5 % |
| Colorant (Base) |
§ 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.