(138 days)
JuellCure Hard is intended for use as a permanent hard relining for total and partial dentures. Hard permanent total or partial relining for restoring partial and complete dentures. Lengthening denture margins.
JuellCure hard is a cold-curing, hard relining material for permanently relining dentures.
The provided text describes the 510(k) summary for the JuellCure Hard, a hard impression material for relining dentures. The submission aims to demonstrate substantial equivalence to a predicate device, Ufi Gel Hard C (K030916).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate Device K030916) | Reported Device Performance (JuellCure Hard) |
|---|---|---|
| Setting Time | 135-180 seconds | 135-180 seconds |
| Appearance | Paste is a colorless, homogenous liquid and the catalyst is a white homogenous paste. | Paste is a colorless, homogenous liquid and the catalyst is a white homogenous paste. |
| Composition of Catalyst | Matrix 40-60%, Filler 30-40%, Catalyst 2-4%, Modifier 6-7%, Stabilizer |
§ 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.