(138 days)
Not Found
No
The summary describes a silicone-based relining material and its physical properties, with no mention of AI or ML.
Yes.
The device is intended to relieve pressure, cushion alveolar processes, and address issues like flabby ridge, which are therapeutic interventions for dental patients.
No
The device description states it is a "permanently soft relining material for removable dentures" and the intended use describes its function in relieving pressure, damming lines, and cushioning processes. There is no indication that it measures, analyzes, or interprets physiological data to diagnose a condition.
No
The device description clearly states it is a "self-curing, silicone-based and permanently soft relining material," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for relining dentures, which is a dental procedure performed directly on a patient's prosthetic device. IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is a material used for relining dentures, not a test or assay for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information about a patient's health status.
The device is a medical device, specifically a dental material, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
JUELL Soft Cure 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
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The working time and setting time were determined for the Soft Cure base, catalyst, glazing base, and glazing catalyst. The surface hardness (Shor hardness A), and adhesion to dentures was determined.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Test Item | JUELL Soft Cure | Ufi Gel SC |
|---|---|---|
| Surface hardness | ||
| (Shore hardness A) | 26.3 | 26.3 |
| Adhesion to dentures | 190 N | 190 N |
| Working time | 201 s | 201 s |
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KIII78
510k Summary
SEP 1 2 2011 July 13, 2011
Trade Name: JUELLCure Soft
Common Name: soft impression material
Company Contact:
John Roderick, Operations Manager Juell Dental 2401 N. Commerce Ardmore, OK 73401 (580) 798-4414
Device Classification: resin, denture, relining, rebasing
Device CFR Section: 21 CFR 872.3760
FDA Device Class: Class II
FDA Product Code: EBI
Classification Panel: Dental
Device Description: JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.
Indications for Use:
JUELL Soft Cure 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
Testing
The working time and setting time were determined for the Soft Cure base, catalyst, glazing base, and glazing catalyst. The surface hardness (Shor hardness A), and adhesion to dentures was determined.
Predicate Device: Ufi Gel SC, K974772, VOCO GmbH, Germany
1
511178
Substantial Equivalence
The material composition of Ufi Gel SC and Juel Soft Cure are very similar. The indications for use are the same. The surface hardness, adhesion time and working time are the same.
| Function | JUELL Soft Cure | Ufi Gel SC |
|---|---|---|
| Monomer Matrix | 70-80 % | 70-80 % |
| Rheologic Modifier | 15-30 % | 15-30 % |
| Catalyst | 0,1-0,5 % | 0,1-0,5 % |
| Monomer Matrix | 70-80 % | 70-80 % |
| Rheologic Modifier | 15-30 % | 15-30 % |
| Colorant |