(89 days)
The ESTECEM device is an adhesive resin cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for:
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Repair of fractured porcelain fused to metal crowns and all ceramic restorations
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Cementation of veneers
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Cementation of adhesion bridges
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Cementation of metal or resin cores, metal or glass-fiber posts
The ESTECEM device is a dual-cure (light and/or self-cure), radiopaque, adhesive resin cement system with excellent handling, esthetic and adhesive properties to teeth and all prosthetic materials. The main components of the ESTECEM device are (1) the paste (A/B) and (2) primer kit. The paste and primer are packaged in plastic syringes and plastic bottles, respectively. The device also comes with a mixing dish (dispensing well), disposable applicator, and cement mixing tip.
The paste is dispensed in an automix syringe and is available in various shades (universal, clear, brown and white-opaque). The primer kit components consist of ESTELINK (bond A/bond B) and Tokuyama Universal Primer (A/B). The ESTELINK bond promotes the adhesion of the paste to the tooth structure. The Tokuyama Universal Primer enhances the adhesion of the paste to prosthetic materials.
The ESTECEM device does not come sterilized and is not intended to be sterilized prior to use.
This document describes the premarket notification for the ESTECEM dental adhesive resin cement system. The acceptance criteria and the study proving the device meets these criteria are detailed in section "807.92(b)(1): Non-clinical Testing" and the "Predicate devices" table, primarily through non-clinical bench testing and comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for ESTECEM are primarily demonstrated through non-clinical testing, comparing its performance to established standards (ISO 4049:2009, ISO 7405:2008) and the technological characteristics of predicate devices. The document does not provide a direct table of set acceptance values versus measured values for each criterion. Instead, it states that the ESTECEM device's material properties, principles of operation, and performance characteristics are comparable to the selected predicates and that it is as safe, as effective, and performs as well as or better than the predicate devices.
However, based on the non-clinical testing performed, we can infer the tested parameters as the acceptance criteria domains:
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Film thickness | "comparable to the selected predicates" (implied to meet relevant ISO standards for dental cements) |
| Working time | "comparable to the selected predicates" (implied to meet relevant ISO standards for dental cements) |
| Setting time | "comparable to the selected predicates" (implied to meet relevant ISO standards for dental cements) |
| Flexural strength | "comparable to the selected predicates" (implied to meet relevant ISO standards for dental cements) |
| Water sorption | "comparable to the selected predicates" (implied to meet relevant ISO standards for dental cements) |
| Color stability | "comparable to the selected predicates" (implied to meet relevant ISO standards for dental cements) |
| Radio-opacity | "comparable to the selected predicates" (implied to meet relevant ISO standards for dental cements) |
| Tensile strength | "comparable to the selected predicates" (implied to meet relevant ISO standards for dental cements) |
| Biocompatibility | Deemed acceptable based on testing in accordance with ISO 7405:2008, ISO 10993-1:2009, ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity). Concluded to be "as safe" as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/ML device. Instead, the performance was evaluated through non-clinical bench testing of the ESTECEM dental adhesive resin cement. The specific sample sizes for each physical property and biocompatibility test are not provided in this summary.
The data provenance is retrospective, as it involves laboratory testing of the manufactured device. The country of origin for the testing data is not explicitly stated, but the manufacturer, Tokuyama Dental Corporation, is based in Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device approval that relies on physical and chemical bench testing and biocompatibility assessments, not on expert adjudication of diagnostic outputs.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
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 dental material device, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental material device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was defined by established International Organization for Standardization (ISO) standards for dental materials. Specifically:
- Physical Properties: ISO 4049:2009
- Biocompatibility: ISO 7405:2008, ISO 10993-1:2009, ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity).
The performance of the ESTECEM device was compared against the requirements and typical performance characteristics of legally marketed predicate devices, implying that the established performance of these predicates served as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a dental material device and does not involve AI/ML models that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.