(130 days)
R&D Series Nova Compo N is a light-curing, radiopaque, nano-hybrid universal composite for anterior restorations. It is intended for professional use by below mentioned Indications for Use;
- · Restorations of deciduous teeth
- · Splinting of mobile teeth
- · Restoration in the posterior region (Classes I and II)
- · Anterior restorations (Classes III, IV)
- · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- · Extended fissure sealing in molars and premolars
- · Veneering of discoloured anterior teeth
- · Repair of composite and ceramic veneers
R&D Series Nova Compo N is a light-curing, radiopaque, nano hybrid composite for anterior and posterior restorations.
According to the applicable FDA recognized consensus standard: ISO 4049:2009 "Dentistry-Polymer Based Restorative Materials", this device is classified into the following:
- -Type 1: polymer-based filling and restorative materials;
-Class 2: Materials whose setting is effected by light;
-Group 1: Materials whose use requires the energy to be applied intra-orally.
R&D Series Nova Compo N light cure nano hybrid composite is designed with the high reduced shrinkage resin. The higher molecular weight of the resin results in less shrinkage, reduced aging and a slightly softer resin matrix. Additionally these resins impart a greater hydrophobicity and are less water absorption. Prepolymerized fillers provide low stress, non-sticky, easy handling and shaping formulation. High loading Prepolymerized fillers provide better wear resistance than traditional less loaded Prepolymerized fillers in other marketing composites. The nanofillers provide high polish, high wear, surface hardness and making the material smooth.
R&D Series Nova Compo N light cure nano hybrid composite was tested for biocompability and found to be biocompatible as a result of testing.
The user is asking for specific details about the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) summary.
Here's an analysis of the provided text and the answers to your questions:
The provided document is an FDA 510(k) premarket notification for a dental composite material, R&D Series Nova Compo N. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through comparison to established standards (like ISO) and predicate device performance, along with bench testing.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, it presents the performance of the new device (R&D Series Nova Compo N) in comparison to the performance of its predicate devices, implying that performance similar to or better than the predicates, and adherence to relevant ISO standards, constitutes the "acceptance criteria."
The closest representation of this is Table 1 in the "Substantial Equivalence" section of the document, which compares the physical properties of the new device with its predicates. The "acceptance criteria" can be inferred as being at least equivalent to the predicate devices and meeting the requirements of the ISO 4049:2009 standard.
Inferred Acceptance Criteria and Reported Device Performance (from Table 1 and text):
| Physical Property | Device Acceptance Criteria (Inferred from Predicates & ISO 4049:2009) | R&D Series Nova Compo N Performance |
|---|---|---|
| Compressive Strength (MPa) | ≥ 250 MPa (based on predicate Tetric Evoceram) | 360 |
| Flexural Strength (MPa) | ≥ 118 MPa (based on predicate Clearfil Majesty Esthetic) | 130 |
| Depth Of Cure (mm) | > 1.5 mm (based on predicates) | ≥ 2 |
| Particle Size Range | Similar to predicates (40 nm - 3 µm is acceptable) | 40 nm and 3 µm. |
| Water Sorption (µg/mm³) | ≤ 25.3 µg/mm³ (based on predicate Clearfil Majesty Esthetic) | 21.2 |
| Water Solubility (µg/mm³) | ≤ 1.5 µg/mm³ (based on predicate Clearfil Majesty Esthetic) | ** |
§ 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.