(54 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 PLT (PLT: Pre-loaded tip) 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. CLEARFIL MAJESTY Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.
CLEARFIL MAJESTY Posterior PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Posterior, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device, except for the color. The applicant device is substantially equivalent to the predicate devices.
This document is a 510(k) premarket notification for a dental restorative material, not a software or AI-powered device. Therefore, many of the requested elements for an AI/software device study are not applicable or present in this submission.
Based on the provided text, here's a breakdown of the acceptance criteria and the "study" (validation) for the device:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Uses (Functionality) | The device (CLEARFIL MAJESTY Posterior PLT) is intended for: |
| 1) Direct restorations for anterior and posterior teeth (Class I - V cavities) | Implicitly met by substantial equivalence claim to predicate devices with these indications. |
| 2) Correction of tooth position and tooth shape (e.g., diastema closure, dwarfed tooth, etc.) | Implicitly met by substantial equivalence claim to predicate devices with these indications. |
| 3) Intraoral repairs of fractured crowns/bridges | Implicitly met by substantial equivalence claim to predicate devices with these indications. |
| Chemical Composition / Safety | All chemical compositions are exactly the same as the predicate device (CLEARFIL MAJESTY Posterior), suggesting substantial equivalence in safety. |
| Effectiveness / Performance (Physical Properties) | Complies with the requirements of ISO 4049:2000 "Dentistry - Polymer-based filling, restorative and luting materials." Both the applicant device and the predicate device (CLEARFIL MAJESTY Posterior) comply with this standard, indicating the applicant device is as effective and performs as well. |
| Biocompatibility | All chemical compositions have been used in the predicate devices, indicating substantial equivalence in biocompatibility. |
| Substantial Equivalence (Overall comparison to predicate devices) | The device is deemed "substantially equivalent" to predicate devices (CLEARFIL MAJESTY Posterior and CLEARFIL AP-X PLT). The only difference is the container form (pre-loaded tips vs. syringes), and the tips themselves are the same as another predicate (CLEARFIL AP-X PLT) except for color. |
Study Information (as applicable to this type of device submission):
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not describe a clinical study of the device that would involve a "test set" in the context of an AI/software device. The validation is primarily based on bench testing against an international standard (ISO 4049:2000) and a comparison of chemical compositions and intended uses to existing predicate devices.
- No specific sample sizes for physical property testing (as would be done for ISO 4049) are provided in this summary.
- No information on data provenance for testing is provided, beyond the standard itself being international.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of this device, is adherence to a recognized international standard for dental materials and chemical composition.
-
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 or imaging device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for demonstrating substantial equivalence is:
- Compliance with ISO 4049:2000 for physical properties.
- Identical chemical composition to a predicate device.
- Similar intended uses to predicate devices.
- Prior safe use of the chemical components in other legally marketed devices.
- The "ground truth" for demonstrating substantial equivalence is:
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
Key Takeaways from the 510(k) Summary:
The manufacturer is seeking Substantial Equivalence for a new form factor (pre-loaded tips) of an existing dental restorative material. The core of their argument is:
- Chemical Identity: The new device has the exact same chemical composition as a previously cleared predicate device (CLEARFIL MAJESTY Posterior).
- Performance Standard Compliance: Both the new device and a predicate device meet the requirements of the international standard ISO 4049:2000 for dental polymer-based restorative materials.
- Use of Previous Components: The pre-loaded tips themselves are adopted from another existing predicate device (CLEARFIL AP-X PLT), with only a color change.
- Identical Intended Uses: The indications for use are equivalent to the predicate devices.
This type of 510(k) relies heavily on demonstrating that the new device is fundamentally the same as a legally marketed predicate device, rather than requiring extensive new clinical trials or complex AI model validation.
§ 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.