(41 days)
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.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.