(115 days)
- Liner or base
- Blocking out undercuts
- Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins are in enamel
- Sealing hypersensitive areas
- Fissure sealant
- Direct restorative for Class I, II, III, IV, V cavities
- Core build-up
NMF004A is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is used for the restorations of both anterior and posterior teeth. The material is available in 30 shades.
The provided text describes a 510(k) premarket notification for a dental device named NMF004A. This document asserts the device's substantial equivalence to previously cleared predicate devices by outlining its characteristics, indications for use, and performance bench tests against a recognized standard (ISO 4049:2009).
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states that "The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials)." While specific measured values for NMF004A are not explicitly provided in the table, the text implies that NMF004A's performance meets these requirements. The table below presents the acceptance criteria from ISO 4049:2009 as listed in the document.
| Property | Acceptance Criteria (from ISO 4049:2009) | Reported Device Performance (NMF004A) |
|---|---|---|
| Sensitivity to ambient light | Remain physically homogeneous | Complies |
| Depth of cure | Opaque shade: > 1.5mm | |
| Other shade: > 2.0mm | Complies | |
| Flexural strength | > 80 MPa | Complies |
| Water sorption |
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.