LogoFDA 510(k) Search
K Number
K170834
Device Name
CERABIEN ZR
Manufacturer
Kuraray Noritake Dental Inc.
Date Cleared
2017-10-17

(211 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use in prosthetic dentistry to create an all-ceramic prosthesis.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the device "Cerabien Zr," which is classified as "Porcelain Powder For Clinical Use." This document primarily addresses the administrative aspects of the device's clearance and its intended use, not the technical study details, performance metrics, or acceptance criteria.

Therefore,Based on the provided text, there is no information available to answer the request about acceptance criteria and the study that proves the device meets those criteria. The document is an FDA clearance letter, which confirms the device's substantial equivalence to a predicate device, but it does not detail the technical performance studies or the specific acceptance criteria used for such studies.

Here's why each point cannot be addressed:

  1. A table of acceptance criteria and the reported device performance: Not provided in the document.
  2. Sample sized used for the test set and the data provenance: Not provided in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
  4. Adjudication method for the test set: Not provided in the document.
  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: This device is "Porcelain Powder For Clinical Use," not an AI-assisted diagnostic device, so an MRMC study related to AI assistance would be irrelevant and is not mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental material, not an algorithm.
  7. The type of ground truth used: Not provided in the document.
  8. The sample size for the training set: Not applicable for this type of device, and not provided.
  9. How the ground truth for the training set was established: Not applicable for this type of device, and not provided.

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.