(80 days)
- Direct restorations for anterior and posterior teeth (Class I - V cavities)
- Direct veneers
- Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- Intraoral repairs of fractured crowns/bridges
CLEARFIL MAJESTY Esthetic is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it suitable for a wide range of 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 § 872 since it is composed of materials such as 2, 2'-Bis-[p-( 7 -methacryloxy- 3 -hydroxypropoxy) phenyl] propane (Bis-GMA). According to the applicable FDA recognized consensus standard, ISO 4049, 2000 "Dentistry - Polymer-based filling, restorative 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; Class 2. materials whose setting is the energy to be applied intra-orally.
This document describes the 510(k) submission for CLEARFIL MAJESTY Esthetic, a light-cure, radiopaque restorative composite resin. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the format of a clinical trial.
Acceptance Criteria and Device Performance Table:
Given the nature of the provided text, which is a 510(k) summary for a dental restorative material rather than a clinical study report for an AI/medical imaging device, the acceptance criteria are not presented in terms of clinical performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are compliance with a recognized standard and demonstrated equivalence to predicate devices in specified physical and chemical properties.
| Acceptance Criteria (from ISO 4049, 2000 "Dentistry – Polymer-based filling, restorative and luting materials") | Reported Device Performance (CLEARFIL MAJESTY Esthetic) |
|---|---|
| Compliance with physical property requirements for Type 1 (polymer-based filling and restorative materials), Class 2 (light-cured materials requiring energy applied intra-orally) | Verified to comply with ISO 4049, 2000. The submission states, "CLEARFIL MAJESTY Esthetic, the applicant device, is verified to comply with the applicable FDA recognized consensus standard, ISO 4049, 2000, 'Dentistry - Polymer-based filling, restorative and luting materials'". |
| Demonstrates "as effective as and performs as well as" predicate devices based on physical properties and chemical ingredients. | Demonstrated to be "as effective as and performs as well as the predicate devices" according to ISO 4049 requirements. The submission states, "As to compare with physical properties of the predicate devices according to ISO 4049, 2000 indicating that the applicant device is as effective as and performs as well as the predicate devices." Additionally, "All the chemical ingredients of CLEARFIL MAJESTY Esthetic, the applicant device, are substantially equivalent to the predicate devices indicating that the safety of the applicant device is substantially equivalent to the predicate devices." |
Study Details (based on the provided 510(k) summary):
The provided document is a 510(k) summary, which is a premarket notification to the FDA. It does not describe a clinical study in the way one would for an AI or diagnostic imaging device. Instead, it demonstrates compliance with a recognized consensus standard (ISO 4049) and substantial equivalence to existing predicate devices (CLEARFIL AP-X, TETRIC EVOCERAM, GRADIA DIRECT) based on laboratory testing of physical properties and chemical composition.
Therefore, the following points cannot be answered as they pertain to clinical studies, which are not detailed in this 510(k) submission:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical test set for AI performance is described. The "test set" here refers to samples of the material tested in a lab for physical and chemical properties. The document does not specify sample sizes for these lab tests or data provenance beyond the general information about the submitter (Kuraray Medical Inc., Japan).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established in this document. The "ground truth" for material properties would be the specifications outlined in ISO 4049.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the material's properties is based on the specifications within the ISO 4049 standard. For equivalence, it's a comparison to the established properties of predicate devices.
- The sample size for the training set: Not applicable. There is no "training set" as this is not an AI or machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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.