FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

Device Description

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 casy handling and placement.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: CLEARFIL MAJESTY Posterior (KURARAY MEDICAL INC.)
Device Type: Light-cure, radiopaque restorative composite resin (Tooth shade resin material)

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission leverages the concept of "substantial equivalence" to a predicate device (K063595). Therefore, the acceptance criteria are primarily based on meeting the same performance standards as the predicate device and complying with a recognized international standard.

Acceptance Criterion	Reported Device Performance
Intended Uses	The intended uses of the subject device (CLEARFIL MAJESTY Posterior) are identical to those of the predicate device.
Chemical Ingredients / Safety	All chemical ingredients of the subject device have been used in the predicate device. The chemical composition is "very similar" to the predicate device. This similarity suggests equivalent safety. The predicate device's safety was previously established and it had no reported problems or recalls for 2 years. Conclusion: Biologically safe.
Effectiveness / Performance (Physical/Mechanical Properties)	Evaluated according to ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" in comparison with the predicate device. Both the subject device and the predicate device comply with ISO 4049:2000. This indicates that the subject device is "as effective as and performs as well as" the predicate device.
Biocompatibility	All chemical ingredients are the same as the predicate device. The predicate device's biocompatibility was established in its original application and it had no reported problems or recalls for 2 years post-market. Conclusion: Biologically safe.
Radiopacity	The device is described as "radiopaque," which is a property often required for restorative materials to be visible on radiographs. (While not explicitly listed as a test result, its mention in the description implies it meets the standard for this characteristic.)
Color Matching, High Polishability, Optimal Viscosity	These are described as characteristics of the device, implying they meet expected standards for clinical performance. Although quantitative acceptance criteria are not presented in this document, these attributes are inherent to the device's design and intended clinical benefits, aligning it with the performance expected of a "tooth shade resin material" for aesthetic and functional restorations.

2. Sample Size for Test Set and Data Provenance

The primary study cited is a comparison of physical and mechanical properties based on ISO 4049.

Sample Size (Test Set): Not explicitly stated in the provided text. The document mentions "physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device." ISO standards typically define the number of samples required for specific tests, but the exact number used in this particular evaluation is missing.
Data Provenance: The study was conducted by KURARAY MEDICAL INC., which is based in Japan ("1621 Sakazu, Kurashiki, Okayama 710-0801, Japan"). The testing described appears to be prospective laboratory testing for the purpose of premarket submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission relies on an equivalency study to a predicate device and compliance with an international standard (ISO 4049) for physical and mechanical properties. There is no mention of a clinical study or expert review to establish ground truth for a test set in the traditional sense, as this is a material science testing rather than a diagnostic or interpretive device.

4. Adjudication Method for Test Set

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a material science product; MRMC studies are typically for diagnostic imaging devices or algorithms where human interpretation is involved.

6. Standalone Performance Study

Yes, in essence. The evaluation of the device's physical and mechanical properties against ISO 4049 and in comparison to the predicate device can be considered a standalone performance study in the context of material science. The algorithm, in this case, is the material itself and its inherent properties.

7. Type of Ground Truth Used

ISO 4049: 2000 Standard Requirements: The primary ground truth for performance is the set of specifications and test methods defined by this international standard for "Dentistry - Polymer-based filling, restorative and luting materials."
Predicate Device Performance: The performance characteristics of the legally marketed predicate device (K063595) also serve as a comparative ground truth.

8. Sample Size for Training Set

Not applicable / Not explicitly mentioned. Material science testing typically doesn't involve "training sets" in the way machine learning algorithms do. The "training" for the device design would involve research and development to formulate the material to meet desired specifications, but no data set of this nature is described.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8. The "ground truth" for material development generally stems from established dental material science principles, clinical needs, and the performance characteristics of existing successful products (like the predicate device).

Summary

Regulation Number and Section

§ 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.