Search Results
Found 1 results
510(k) Data Aggregation
(248 days)
Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
Fusion Core DC Flo is indicated for use as core build up material on vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material.
Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts.
Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosion, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations,
Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant.
Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, III, IV and V, and porcelain/ composite repairs.
Fusion Core DC Flo is dual-curing, radiopaque, flowable restoration for core build-up composite supplied in an auto-mix delivery system.
Fusion Flo is a flowable composite of medium viscosity used for fillings in anterior teeth and small fillings in posterior teeth. Fusion Flo can be used separately or with Magma-NT composites.
Fusion Flo SE is a self-etch, self-adhesive flowable composite. The flowable composite is ready for use and doesn't require the preparatory steps of etching, priming and bonding. Fusion Flo SE can be used separately or with Magma-NT composites.
Fusion I-Seal is a single component, light cured flowable composite.
Magma-NT is a visible light cured, radio opaque highly filled hybrid composite restorative material for anterior and posterior restoration of all teeth.
The provided text describes the acceptance criteria and performance of several dental composite resins from Prevest Denpro Limited (Fusion Core DC Flo, Fusion Flo SE, Fusion I-Seal, and Magna NT) as part of a 510(k) premarket notification to the FDA. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting the requirements of ISO 4049:2019 and ISO 13116:2014, with specific values mentioned for some parameters. The reported device performance indicates that "All test results met the criteria in standards."
| Device Property | Acceptance Criteria (Standard / Value) | Reported Device Performance |
|---|---|---|
| Fusion Core DC Flo | Based on ISO 4049:2019 & ISO 13116:2014 | Met criteria in standards. Specific values for Flexural Strength (≥50 MPa), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (maximum of 40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³), Working Time (1:25), Setting Time (3:20). |
| Fusion Flo | Based on ISO 4049:2019 & ISO 13116:2014 | Met criteria in standards. Specific values for Flexural Strength (≥ 80 MPa), Depth of Cure (1.00 mm opaque / 1.5 mm others minimum), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (≤40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³). |
| Fusion Flo SE | Based on ISO 4049:2019 & ISO 13116:2014, USP 971 (for pH) | Met criteria in standards. Specific values for Flexural Strength (≥ 80 MPa), Depth of Cure (1.00 mm opaque / 1.5 mm others minimum), Radio Opacity (3mm compared with aluminium wedge), Water Sorption ( |
Ask a specific question about this device
Page 1 of 1