(67 days)
- Direct restorations for anterior and posterior teeth (Class I - V cavities)
- Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- Intraoral repairs of fractured crowns/bridges
CLEARFIL MAJESTY Posterior is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. It is classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR section 872 since it is composed of materials such as 2,2'-Bis-[p-( Y -methacryloxy- 3 -hydroxypropoxy) phenyl] propane (Bis-GMA). According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, res orative and luting materials", this device is classified into the following: -Type 1: polymer-based filling and restorative materials; - Class 2: materials whose setting is effected by light; - Group 1: materials whose use requires the energy to be applied intra-orally.
The provided text describes a 510(k) summary for a dental restorative material, CLEARFIL MAJESTY Posterior. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study of its own with specific acceptance criteria and performance metrics in the way one might expect for a diagnostic AI device.
Therefore, the requested information components related to an AI device's performance study (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document. This document primarily addresses the chemical composition, intended use, and compliance with general dentistry standards (ISO 4049:2000).
Here's an attempt to extract and frame the relevant information based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are implied by compliance with established industry standards and substantial equivalence to predicate devices, rather than specific performance metrics measured in a clinical study as would be seen for a diagnostic AI.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" (Type 1, Class 2, Group 1) | Verified to comply with ISO 4049:2000. (Section 3-4, 3-5.3) |
| Chemical composition safety and effectiveness (Substantial Equivalence) | All chemical ingredients have been used in predicate devices, indicating substantial equivalence in safety and effectiveness. (Section 3-5.2, 3-6) |
| Intended Uses | Compatible with the intended uses of predicate devices for direct restorations, correction of tooth position/shape, and intraoral repairs. (Table 3, Section 3-5.1) |
2. Sample size used for the test set and the data provenance
- Not Applicable: This document does not describe a performance study with a "test set" in the context of an AI device. The equivalence is based on material properties and chemical composition.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method for the test set
- Not Applicable: No test set or adjudication method is described.
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 not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable: The "ground truth" for this submission revolves around chemical composition, material properties, and compliance with ISO standards, evaluated against existing predicate devices and recognized standards, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
- Not Applicable: This is not an AI device and does not involve a training set.
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI device and does not involve a training set.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.