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K Number
K193090
Device Name
HCG Zirconia Ceramic Block
Manufacturer
Hocheng Corporation
Date Cleared
2020-10-29

(358 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K092496,K130991
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

HCG Zirconia Ceramic Block are intended for the fabrication of copings and full anatomical/full contour crowns, bridges, inlays, and onlays for anterior and posterior segment restorations.

Device Description

"HCG Zirconia Ceramic Block" is a ceramic block composed of zirconia compounds. It is suitable for manufacture of dental crowns and bridges cut in the conventional manner or with the help of CAD/CAM.

AI/ML Overview

The provided text describes the 510(k) summary for the HCG Zirconia Ceramic Block, which is a dental device. The information details non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria for an AI/ML-driven medical device.

Therefore, the document does not contain the requested information regarding:

  • A table of acceptance criteria and reported device performance for an AI/ML device.
  • Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, or how ground truth for training data was established.

This document focuses on the physical and chemical properties, biocompatibility, and functional testing of a zirconia ceramic block against established standards (e.g., ASTM, ISO) to demonstrate its equivalence for dental restorations. It explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

In summary, this document is not a study proving an AI/ML device meets acceptance criteria. It is a submission for a dental material (zirconia block) based on non-clinical performance and substantial equivalence to existing predicate devices.

§ 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.