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K Number
K012707
Device Name
ESTENIA
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-13

(30 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K982164
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ESTENIA is used for the following cases:

    1. Jacket crown
    1. Facing crown
    1. Inlay and onlay
Device Description

ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for laboratory fabrication of jacket crown, inlay and onlay restorations.

AI/ML Overview

The provided document is a 510(k) summary for a dental material called ESTENIA. It states that the submission aims to alter the manufacturer's name and address, and not to intend other changes to the device itself. Therefore, the device's technological characteristics, chemical ingredients, and safety are completely the same as the predicate device (K982164).

This means the submission does not contain a new study demonstrating that the device meets acceptance criteria because it is essentially a rebranding/transfer of ownership of an already approved device. The "acceptance criteria" and "study" would have been part of the previous 510(k) submission (K982164) for the original ESTENIA device by Kuraray Co., Ltd.

Based on the provided document, the following information cannot be extracted because no new study was conducted for this specific 510(k) submission:

  1. A table of acceptance criteria and the reported device performance: Not provided. The document explicitly states the device is identical to the predicate.
  2. Sample size used for the test set and the data provenance: Not provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
  4. Adjudication method for the test set: Not provided.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental material, not an AI or imaging device with human reader interaction.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material.
  7. The type of ground truth used: Not provided.
  8. The sample size for the training set: Not applicable. This device is a dental material, not a machine learning algorithm.
  9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission relies on the substantial equivalence principle, asserting that the device (ESTENIA by Kuraray Medical Inc.) is identical to its predicate device (ESTENIA by Kuraray Co., Ltd., K982164). Therefore, no new efficacy or performance studies are presented in this document.

§ 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.