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ProGlass One: Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges; Cementation of orthodontic bands; Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns; Base/liner
ProGlass Two: Class III, V and limited class I cavities; Restoration of primary teeth; Core Build Up
ProGlass Two LC: Class III and V restorations; Restoration of Cervical erosions and root surface caries; Core Build Up; Base/Liner
ProGlass Nine: Class I & II cavities; Decidious teeth: final restorative for Class I, II and V; Long term restorative in non-load bearing areas of Class I, II and V; Intermediate restorative & sandwich material for heavy stress bearing; Core build up material
ProGlass Plus: Metal-based restorations; Ceramic inlays; Reinforced ceramic crowns and bridges; All kinds of acrylic/resin crowns, inlays, onlays and bridges
ProGlass Silver: Class I, limited Class II, temporary fillings; Restoration of primary teeth; Core Build Up; Base/Liner

The ProGlass cements are classified as a Dental Cement (21 C.F.R. part 872.3275) because they are devices 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.

The provided document is a 510(k) summary for Silmet Ltd.'s ProGlass Cements. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested categories cannot be fully addressed as a formal study with a test set, ground truth experts, and statistical comparisons was not conducted. The submission relies on the established safety and effectiveness of the predicate devices and the components used.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) submission does not detail specific quantitative acceptance criteria for performance metrics (beyond general physical characteristics) that the device must meet, nor does it present a study explicitly comparing the new device's performance against such criteria.

The document includes a table of "Physical characteristics" (Table 2 on page 1) which lists:

• Powder/liquid ratios
• Mixing time
• Working time
• Setting time
• Light Cure time (for ProGlass Two LC)

However, these are presented as characteristics of the ProGlass Cements, not as performance targets or acceptance criteria with corresponding results from a study designed to prove them. The stated acceptable ranges are implicitly derived from the properties of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. No dedicated "test set" in the context of a clinical performance study is described. The submission primarily relies on the well-established properties of the components and the predicate devices.
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. As no clinical performance study with a test set requiring expert ground truth was conducted, this information is not provided.

4. Adjudication Method for the Test Set

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This is a submission for dental cements, not an AI or imaging device, so an MRMC study is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable.

7. The Type of Ground Truth Used

• Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is effectively the established safety and effectiveness of the predicate devices and the individual components, supported by their long history of clinical use.

8. The Sample Size for the Training Set

• Not applicable. There is no training set in the context of an algorithm or AI development.

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (Based on the document):

The "study" described in this 510(k) submission is primarily a comparison to predicate devices and a demonstration of component safety and technological equivalence, rather than an independent clinical performance study with explicit acceptance criteria.

• Basis of Proof: Silmet Ltd. asserts that ProGlass Cements are safe and effective because:

  • All components used in ProGlass Cements are found in legally marketed predicate devices (Fuji I, Fuji II, Fuji II LC, Fuji IX, Fuji Plus, Miracle Mix – all by GC America).
  • The material, design, and use concept of ProGlass Cements are similar to these predicate devices.
  • The prior use of these components in legally marketed devices and the performance data of those devices support the safety and effectiveness of ProGlass Cements, making additional testing for cytotoxicity, mutagenicity, or other biocompatibility studies unnecessary.

• Conclusion: Based on this comparison and component analysis, Silmet Ltd. concludes that ProGlass Cements are substantially equivalent to the predicate devices, thereby meeting the implicit "acceptance criteria" of being as safe and effective as existing legally marketed devices.

This approach is common for Class II medical devices seeking 510(k) clearance, where substantial equivalence to a predicate device eliminates the need for extensive de novo clinical trials unless significant technological differences or new safety/effectiveness questions arise.

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lonolux is intended for the following applications:

1. Restorations class III and V, especially cervical fillings and root caries
2. Fillings on deciduous teeth
3. Small class I fillings
4. Temporary fillings
5. Core build-up
6. Lining

Ionolux is a resin-reinforced radiopaque light-curing glass-polyalkenoate restorative. The material has outstanding aesthetics, good handling properties and high chemical adhesion.

This document describes a 510(k) premarket notification for a dental cement called Ionolux. As such, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

510(k) summaries are primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing comprehensive study results against specific performance criteria. The provided text indicates that:

• Technological characteristics: "All of the components of Ionolux are found in the legally marketed device GC Fuji II LC improved (K961584, GC America, Inc.)"
• Safety and effectiveness: "The prior use of all of the components of Ionolux in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional blocompatibility studies with the final formulation are not necessary. We believe that the prio use of the components of lonolux in legally marketed devices and the performance data and results provided support the safety and effectiveness of lonolux for the intended use."

This essentially states that the device is considered safe and effective because its components are already used in a legally marketed predicate device, and therefore, extensive new testing (like a standalone performance study with detailed acceptance criteria) was deemed unnecessary for this 510(k) submission.

Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study with explicit acceptance criteria.

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