(357 days)
Final cementation of all-ceramic, metal-based inlays, onlays, posts, crown and bridge
EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that does not need pre-treatment process, and it is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2mm Al). And it offers various shades for aesthetics and color stable.
This document describes the performance testing for a dental cement called EsCem, manufactured by SPIDENT Co., Ltd. The purpose of the testing is to demonstrate the substantial equivalence of EsCem to a legally marketed predicate device, G-CEM LinkAce (K120243), manufactured by GC America Inc.
1. Acceptance Criteria and Device Performance
The performance testing was conducted according to various sections of the ISO 4049:2019, Dentistry Polymer-based restorative materials standard. The table below lists the acceptance criteria and the reported device performance for EsCem. Since specific numerical results for EsCem are not provided in the document (only whether it met the requirement), the "Reported Device Performance" column reflects that it met the acceptance criteria. For comparison, the document states that both the subject device and the predicate device meet the requirements of ISO 4049.
| Performance | Test method | Acceptance Requirement | Reported Device Performance (EsCem) |
|---|---|---|---|
| Film thickness | ISO 4049:2019 - 7.5 Measurement of film thickness of luting materials | Shall be no greater than 50 μm. | Met requirement |
| Working time | ISO 4049:2019 - 7.7 Working time, Class 1 and Class 3 luting materials | During its formation there shall be no detectable change in its homogeneity. | Met requirement |
| Setting time | ISO 4049:2019 - 7.8 Setting time, Class 1 and Class 3 materials | Shall be no more than 10 min (600 sec). | Met requirement |
| Flexural strength | ISO 4049:2019 - 7.11 Flexural strength | Shall be equal to or greater than 50 MPa. | Met requirement |
| Water sorption | ISO 4049:2019 - 7.12 Water sorption and solubility | Shall be equal to or less than 40 µg/mm³. | Met requirement |
| Solubility | ISO 4049:2019 - 7.12 Water sorption and solubility | Shall be equal to or less than 7.5 µg/mm³. | Met requirement |
| Radio-opacity | ISO 4049:2019 - 7.14 Radio-opacity | Shall be equal to or greater than that of the same thickness of aluminum. | Met requirement (1.2mm Al stated) |
| Sensitivity to light | ISO 4049:2019 - 7.9 Sensitivity to light, Class 2 materials | The material shall remain physically homogeneous. | Met requirement |
| Color stability | ISO 4049:2019 - 7.13 Shade and colour stability after irradiation and water sorption | No more than a slight change in color shall be observed. | Met requirement |
2. Sample Size for Test Set and Data Provenance
The document does not specify the exact sample sizes used for each performance test (e.g., number of specimens for film thickness, flexural strength, etc.). The provenance of the data is retrospective bench testing, conducted by SPIDENT Co., Ltd. in South Korea.
3. Number of Experts and Qualifications for Ground Truth
This study is a bench performance testing for a dental cement, not an AI/ML medical device. Therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiological reads) does not apply. The ground truth for this device is based on established international consensus standards (ISO 4049:2019) for physical and chemical properties of dental materials.
4. Adjudication Method for Test Set
Not applicable, as this is bench testing against a standard, not a human reader study requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a bench study comparing a new device against a standard and a predicate device's performance through physical and chemical property testing. It is not an MRMC study comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical dental device (cement), not an algorithm or software.
7. Type of Ground Truth Used
The ground truth used for this study is based on established industry standards, specifically ISO 4049:2019 (Dentistry Polymer-based restorative materials). This standard defines the acceptable ranges and properties for dental cements. Additionally, the comparison to a legally marketed predicate device (G-CEM LinkAce) serves as a comparative ground for substantial equivalence.
8. Sample Size for Training Set
Not applicable. This is a physical dental device subjected to bench testing, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no training set for this type of 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.