(119 days)
Infinix™ Universal Composite:
- Restorations in the posterior region (Class I and II)
- Anterior restorations (Class III, IV)
- Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- Veneering of discolored anterior teeth
- Splinting of mobile teeth
- Extended fissure sealing in molars and premolars
- Repair of composite/ceramic veneers
The addition of the QASi particles to the Infinix™ Universal Composite reduces demineralization, which is part of the caries-formation process.
Infinix™ Flowable Composite:
- Class III and V restorations
- Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- As base/liner under direct or indirect restorations
- Repair of small defects in aesthetic indirect restorations
- Pit and fissure sealant
- Blocking out of undercuts
- Repair of resin and acrylic temporary materials
The addition of the QASi particles to the Infinix™ Flowable Composite reduces demineralization, which is part of the caries-formation process.
Infinix™ Bulk Fill Flow Composite:
- Base under Class I and II direct restorations
- Liner under direct restorative materials
- Pit and fissure sealant
- Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- Class III and V restorations
- Blocking out of undercuts
- Repair of small enamel defects
- Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials
- As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown
The addition of the OASi particles to the Infinix™ Bulk Fill Flow Composite reduces demineralization, which is part of the caries-formation process.
The Infinix™ Family of Dental Composites include the following light-cured, resinbased composite materials:
- Universal Composite
- Flowable Composite
- Bulk Fill Flow Composite
Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the Infinix™ composites are decorated with quaternary ammonium functional groups that are covalently bound to the filler particles' silica core via a silane linker (herein referred to as "QASi"). Following light induced polymerization, QASi particles (produced by Nobio) remain permanently entrapped within the composite restoration and destroy microorganisms by contact. As the cell membrane of microorganisms is negatively charged and the QASi particles have strong positive charges, microorganisms are electrostatically attracted to the positively charged cured material's surface resulting in disruption of their cell membrane and immediate microbial lysis.
This document is a 510(k) Premarket Notification from the FDA regarding dental composites. It does not contain information about an AI/ML medical device. Therefore, I cannot provide details on acceptance criteria and study proving device meets criteria as requested in the prompt, as the provided text doesn't describe such a device or study.
The document discusses the substantial equivalence of the "Infinix™ Family of Dental Composites" to their predicate devices, emphasizing a new claim related to the reduction of demineralization due to the addition of QASi particles. The clinical performance section describes an in-situ clinical study comparing a composite with QASi particles to one without, focusing on mineral loss in enamel slabs. This study is for dental materials, not an AI/ML algorithm.
Therefore, I cannot fulfill the request as it pertains to an AI/ML device and its acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies, because this information is not present in the provided text.
§ 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.