(90 days)
Not Found
No
The description focuses on the material properties and application method of a dental cement, with no mention of AI or ML.
No.
This device is a dental cement used for permanent bonding of various indirect dental restorations, which is a structural or restorative function, not a therapeutic one.
No
Explanation: The device is a permanent dental cement used for the cementation of various indirect restorations. Its purpose is to physically bond dental materials, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "radiopaque resin-modified glass ionomer luting cement offered in a paste/paste/paste formulation" and is dispensed from syringes, 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 clearly states that Nexus RMGI is a "permanent dental cement" for "cementation of indirect restorations." This describes a material used in the body to bond dental prosthetics, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a "resin-modified glass ionomer luting cement" in a paste/paste formulation, dispensed through automix tips. This is consistent with a dental cement, not an in vitro diagnostic device.
- Performance Studies: The performance studies focus on characteristics relevant to a dental cement, such as work time, set times, strength, film thickness, and bond strength. These are physical and mechanical properties, not diagnostic performance metrics like sensitivity, specificity, or AUC.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
In summary, Nexus RMGI is a dental material used for bonding, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Nexus RMGI is intended for use as a permanent dental cement. It is indicated for the following indirect restorations:
- Cementation of metal-based inlays, onlays, crowns and bridges
- Cementation of resin inlays, onlays, crowns and bridges
- Cementation of all ceramic inlays
- Cementation of high strength (zirconia based) all ceramic crowns and bridges
- Cementation of metal, ceramic and fiber posts
Product codes
EMA
Device Description
Nexus™ RMGI is a radiopaque resin-modified glass ionomer luting cement offered in a paste/paste/paste formulation that provides an option for tack light-curing of excess cement. This paster formalation that problems of a catalyst packaged in dual-barrel syringes. The base and catalyst are dispensed from the dual-barrel syringe through automix tips.
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
Non-Clinical Test Data: Biocompatibility studies were completed (ISO L929 MEM Elution Test, Nexts Arrenm and Escherichia Coli Reverse Mutation Assay, ISO Intramuscular Implantation Test, ISO Kligman Maximization Test and ISO Oral Irritation Test). Bench testing was conducted to evaluate performance characteristics of Nexus RMGI compared to the predicate device, RelyX Luting Plus Automix. Characteristics evaluated include Work Time, Set Times, Flexural Strength, Compressive Strength, Filler Loading, Translucency, Film Thickness, Consistency of Mixed Paste, Radiopacity, Solubility, Fluoride Release and Bond Strength.
Clinical Test Data: Clinical testing has not been conducted on this product.
Key Metrics
| Descriptive Information | Nexus RMGI | RelyX Luting Plus Automix (K111185) |
|---|---|---|
| Gel Time (or Working Time) @ 22.5 ± 1.0°C | 1'55" | 3'20" |
| Set Time @ 22.5 ± 1.0°C | 3'15" | 6'45" |
| Set Time @ 37.0 ± 1.0°C | 2'20" | 4'45" |
| Flexural Strength (MPa) as per ISO 9917-2:2010 | 36.7 | 20.7 |
| Compressive Strength (Mpa) | 154 | 103 |
| Filler Loading, wt.% | 60.3 | N/A |
| Translucency, % | 39.1 | 16.1 |
| Film Thickness, μm | 9 | 16 |
| Consistency of mixed paste, cm | 2.9 | 3.2 |
| Radiopacity, % Al | 217 | 150 |
| Solubility (7 days), % | 0.28 | 0.94 |
| Cumulative Fluoride Release, ppm - 1 week | 25.7 | 41 |
| Cumulative Fluoride Release, ppm - 4 week | 48.1 | 81.9 |
| Shear Bond Strength to various substrates - Dentin, MPa | 20.2 | 15.6 |
| Shear Bond Strength to various substrates - Enamel (Bovine), MPa | 16.2 | 10.5 |
| Shear Bond Strength to various substrates - Rexillium III, MPa | 26.3 | 12.0 |
| Shear Bond Strength to various substrates - Gold Alloy, MPa | 16.8 | 11.8 |
| Shear Bond Strength to various substrates - Zirconia (Lava), MPa | 17.5 | 13.8 |
| Shear Bond Strength to various substrates - Porcelain (Vitablocs) with HF etch, MPa | 23 | 14.3 |
| Shear Bond Strength to various substrates - Composite (Premise Indirect), MPa | 17.6 | 7.3 |
| Shear Bond Strength to various substrates - Lithium Disilicate , MPa | 17.7 | 14.9 |
| Shear Bond Strength to various substrates - Alumina, MPa | 14.9 | 13.1 |
| Shear Bond Strength to various substrates - Titanium, MPa | 25.2 | 13.4 |
| Shear Bond Strength to various substrates - Post, lbs | 53.9 | 34.8 |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
1