(138 days)
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No
The 510(k) summary describes a cold-curing dental relining material and its performance characteristics, with no mention of AI or ML technology.
No.
The device is a dental relining material used to restore and lengthen dentures, which is a structural rather than a therapeutic function.
No
This device is a dental relining material, used for repairing and restoring dentures, which is a treatment or restorative function, not a diagnostic one.
No
The device description clearly states it is a "cold-curing, hard 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 "permanent hard relining for total and partial dentures." This is a dental procedure performed directly on a patient's dentures, which are medical devices themselves.
- Device Description: The description confirms it's a "cold-curing, hard relining material for permanently relining dentures." This describes a material used in a dental setting for a restorative purpose.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are used to diagnose, monitor, or screen for diseases or conditions by examining these types of samples.
Therefore, JuellCure Hard is a dental material used for relining dentures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
JUELL Hard Cure 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
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
JuellCure hard is a cold-curing, hard relining material for permanently relining dentures.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing including adhesion to denture material, thermocycling, flexural strength, color stability, heat of polymerization, and translucency were conducted. The values for these performance characteristics was found to be very similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
510K Summary
July 13, 2011
KIIII77
Trade Name : JUELLCure Hard
SEP 1 2 2011
Common Name: Hard impression material
Company Contact:
John Roderick, Operations Manager Juell Dental 2401 N. Commerce Ardmore, OK 73401 (580) 798-4414
Classification Name - Resin, denture, relining, repairing, rebasing
CFR Section: 872.3760
FDA Device Class: Class II
FDA Product Code : EBI
Classification Panel : Dental
Device Description: JuellCure hard is a cold-curing, hard relining material for permanently relining dentures.
Indications for Use:
JUELL Hard Cure 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
Performance Testing:
Testing including adhesion to denture material, thermocycling, flexural strength, color stability, heat of polymerization, and translucency were conducted. The values for these performance characteristics was found to be very similar to the predicate device.
Predicate Device: Ufi Gel hard C, K030916, VOCO GmbH, Germany
1
Image /page/1/Picture/0 description: The image contains a series of symbols or characters that appear to be handwritten. The characters include what looks like a capital 'K', followed by four vertical lines, and then two symbols that resemble the number '7'. The writing is somewhat crude and lacks uniformity, suggesting it may be a quick or informal note.
Substantial Equivalence:
| Juell Hard Cure | Ufi Gel Hard C K030916 | |
|---|---|---|
| Indications for Use | JUELL Hard Cure 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 dentureslengthening denture | ||
| margins | Ufi Gel Hard C 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 dentureslengthening denture | ||
| margins | ||
| 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 |