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K Number
K092281
Device Name
CLEARFIL MAJESTY POSTERIOR PLT
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2009-10-27

(90 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K071169
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Direct restorations for anterior and posterior teeth (Class I V cavities)
  2. Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
  3. Intraoral repairs of fractured crowns/bridges
Device Description

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.
In this application, we have precisely defined the amount of dl-Camphorquinone and N.N-Diethanol-p-toluidine (DEPT) contained in CLEARFIL MAJESTY Posterior PLT in range of chemical composition shown in the original application in order to improve its sensitivity to ambient light.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental restorative material, CLEARFIL MAJESTY Posterior PLT. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with new acceptance criteria and performance evaluations for the subject device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in this document.

The document primarily relies on:

  • Comparison of Chemical Composition: The subject device has precisely defined amounts of dl-Camphorquinone and N,N-Diethanol-p-toluidine (DEPT) within the range of the predicate device.
  • Compliance with Standards: The subject device, like the predicate, complies with ISO 4049:2000 "Dentistry - Polymer-based filling, restorative and luting materials" for physical and mechanical properties.
  • Similarity of Intended Use: The intended uses are identical to the predicate device.
  • Biocompatibility by Reference: All chemical ingredients are the same as the predicate and its safety has been previously established and confirmed by the predicate device being on the market for 2 years with no reported problems or recalls.

In lieu of a table of acceptance criteria and reported device performance, the document states:

"Furthermore, physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device, in which the substantial equivalence between the subject device and the predicate device was shown in terms of effectiveness/performance."

And, "As to comparison with the predicate device, according to ISO 4049: 2000, both the subject device and the predicate device comply with ISO 4049: 2000, indicating that the subject device is as effective as and performs as well as the predicate device."

Summary of available information:

  1. A table of acceptance criteria and the reported device performance: Not explicitly stated as acceptance criteria in the context of a new efficacy study. The device's performance is demonstrated by its compliance with ISO 4049:2000, which is also met by the predicate device.
  2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of submission. Performance was shown through compliance with an international standard.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable.
  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
  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 device is a dental restorative material, not an AI diagnostic or assistance tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Compliance with an engineering standard (ISO 4049:2000) was used to demonstrate performance.
  8. The sample size for the training set: Not applicable.
  9. 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.