K Number
K232952
Device Name
Copran Zri
Date Cleared
2024-06-24

(277 days)

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

Copran Zri consists of machinable zirconia discs for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges (anterior and molar.)

Device Description

Pre-sintered zirconia blanks for the fabrication of individual dental restorations.

Copran Zri disks come in both white and pre-shaded light, medium or intense in 95 and 98 mm diameter in thicknesses from 10-25mm.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "Copran Zri," which consists of machinable zirconia discs for dental restorations. The document asserts that this device is substantially equivalent to a predicate device, Ivoclar IPS e.max ZirCad MO (K051705), and references Whitepeaks Copran Zr (K092496).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document implicitly uses the performance of the predicate and reference devices, as well as standards like ISO 6872:2015, to establish acceptance criteria. The table below compiles the reported device performance for Copran Zri in comparison to these.

Acceptance Criteria (from ISO 6872:2015 and Predicate/Reference)Copran Zri PerformanceNotes
Physical Properties
ISO 6872:2015 ClassificationType II Class 5Copran Zri, Copran Zri Light, Medium and Intense all meet this classification, which is consistent with the reference and predicate devices. This standard dictates properties for ceramic materials for dental restorations.
Bending/Flexural Strength (MPa)1400Reported as 1400 MPa for Copran Zri. The predicate device (Ivoclar ZirCad MO) has 1150 MPa, and the reference device (Copran Zr) has 1400 MPa. Copran Zri meets or exceeds the predicate.
Fracture Toughness (MPa·m1/2)5Reported as 5 MPa·m1/2 for Copran Zri. The predicate device has >5.1 MPa·m1/2, and the reference device has 5 MPa·m1/2. Copran Zri is comparable to the reference and close to the predicate.
Solubility (µg/cm²)6.7Reported as 6.7 µg/cm² for Copran Zri. The predicate device has

§ 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.