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K Number
K233064
Device Name
Copra Supreme
Manufacturer
Whitepeaks Dental Solutions GmbH
Date Cleared
2024-09-18

(358 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K092496,K213425
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Copra Supreme zirconia blanks are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Device Description

Pre-sintered zirconia blanks for the fabrication of individual dental restorations. Copra Supreme disks come in both white and pre-shaded 0M1-D4 in various sizes.

AI/ML Overview

The provided document is a 510(k) summary for a dental device (zirconia blanks) and does not describe an AI/ML-enabled device or a study involving human readers or ground truth established by experts. Therefore, I am unable to provide the detailed information requested regarding acceptance criteria and performance evaluation of an AI device.

The document primarily focuses on establishing substantial equivalence for a physical dental material (zirconia blanks) to legally marketed predicate devices. The "Testing Summary" section on page 5 states: "The physical properties of Copra Supreme were tested according to ISO 6872:2015 and all parameters meet the standard. Flexural strength, coefficient of thermal expansion, solubility and radioactivity were tested." This refers to material property testing, not performance criteria for a diagnostic AI algorithm.

The table presented on pages 6-7 compares the characteristics of the subject device (Copra Supreme zirconia blanks) to predicate and reference devices, including:

  • Acceptance Criteria/Performance Metrics (as reported for a physical material):
    • Flexural Strength (MPa)
    • Fracture Toughness (MPa·m1/2)
    • Solubility (µg/cm²)
    • Radioactivity (Bq·g-1 238U)

Since the request is about an AI/ML device and the provided document is for a physical dental material, most of the requested fields are not applicable.

§ 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.