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K Number
K213147
Device Name
CERABIEN MiLai
Manufacturer
Kuraray Noritake Dental Inc.
Date Cleared
2022-03-28

(182 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.

  • Ceramic for coverage of a zirconia substructure
  • Ceramic for coverage of a lithium disilicate substructure [CTE: 10.2-10.5×10-6/K (50-500°C)]
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a dental prosthetic material, CERABIEN MiLai. It does not contain any information about acceptance criteria for device performance, the study design, or results of any performance studies (e.g., clinical or technical validation studies for an AI/ML powered medical device).

Therefore, I cannot extract the requested information. The document pertains to the regulatory clearance of a material, not a software or AI device that would have such performance criteria and studies.

§ 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.