KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60

• K Number: K032081
• Device Name: KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60
• Manufacturer: KAVO AMERICA
• Date Cleared: 2003-07-24 ( 17 days)
• Product Code: EIH
• Regulation Number: 872.6660
• Type: Special
• Panel: DE
• Reference & Predicate Devices: K022996

Intended Use

The KaVo Everest® ZS-Blank is used in the manufacture of dental prosthetics.

Device Description

The KaVo Everest® ZS-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics

AI/ML Overview

This 510(k) submission for the KaVo Everest® ZS-Blank does not include a study or acceptance criteria related to a performance study of the device.

Instead, the submission states:

Performance Data: "None required. The claim of substantial equivalence is based on comparisons of formulations and intended uses of the KaVo devices to legally marketed predicates and to the IDENTIFICATION of porcelain powders in 21 CFR 872.6660."

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data from a study for this specific device. The device's approval was based on demonstrating substantial equivalence to predicate devices, focusing on formulation and intended use, rather than a clinical performance study with specific metrics.

Regulation Number and Section

§ 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.