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Primary teeth restorations
Small Class I restorations
Class III and Class V restorations
Transitional restorations
Filling defects and undercut areas in crown preparations
Core buildup where at least half the coronal tooth structure is remaining to provide structural support for the crown
Laminate sandwich technique

LCR is a light curing, radiopaque, fluoride-releasing, resin-modified glass ionomer restorative system. The restorative system consists of a base and catalyst paste and a primer. LCR is available in 8 shades. The restorative paste will be available in both the multi-dose 3M ESPE Clicker dispensing system or a unit dose option.

The provided document does not contain information about acceptance criteria and a study proving a device meets them in the format requested.

This document is a 510(k) Summary of Safety and Effectiveness for the LCR, Light-Curing Glass Ionomer Restorative System. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for performance and then proving them through a dedicated study.

Here's why the requested information cannot be fully extracted based on the provided text:

• Acceptance Criteria and Reported Device Performance (Table 1): The document states that LCR is designed to retain the excellent physical, mechanical and clinical properties of existing Vitremer Core Buildup/Restorative System. It also mentions that the performance characteristics of LCR were compared to 3M ESPE Vitremer Core Buildup/Restorative System, 3M ESPE Photac-Fil Aplicap and GC Fujill LC. However, it does not enumerate specific performance metrics with their acceptance criteria and the corresponding reported values for LCR. It broadly claims similarity in properties.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study (Points 2-7): The document describes a comparison of LCR's performance characteristics with predicate devices and biocompatibility testing by independent research institutes. These are not clinical studies in the sense of evaluating a diagnostic algorithm against a ground truth established by experts. There is no mention of test sets, experts, adjudication methods, or MRMC/standalone performance as would be relevant for devices involving diagnostic or interpretive algorithms. Cosmetic/device characteristic studies often do not use these methods.
• Training Set Sample Size and Ground Truth (Points 8-9): Since this is not a study involving machine learning algorithms that require training data, there is no mention of a training set or how its ground truth would be established.

In summary, the provided document focuses on demonstrating substantial equivalence of a modified dental restorative system regarding its chemical composition, intended use, shelf life, storage conditions, and general safety and effectiveness through comparison to existing predicate devices, rather than a study with defined acceptance criteria and detailed performance metrics as would be typical for a diagnostic or AI-driven device.

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The CoJet™-System's intraoral adhesive restoration repair and adhesive cementation uses include:

• adhesive repair of defects in porcelain
• adhesive repair of defects in porcelain with exposed metal -
• adhesive repair of defects in composite -
• adhesive repair of defects in composite with exposed metal
• conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc.
• conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.

4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System. The components are CoJet™-Sand, a silane coupling agent, a bonding material, and an Opaquer.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML or diagnostic performance. The document is a 510(k) summary for a dental adhesive system (CoJet™-System) and focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information, as there is no data related to:

1. Acceptance criteria and reported device performance in a diagnostic sense (e.g., sensitivity, specificity, AUC).
2. Sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance in the context of an AI/ML device or diagnostic test.

The document discusses the regulatory clearance of a dental product based on its components and their prior clearances, with a brief mention of "performance data demonstrate that the products' performance is not affected by intraoral preparation and use." However, it does not elaborate on what this performance data entails, nor does it present specific metrics or study designs relevant to the questions asked.

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