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K Number
K980986
Device Name
PROCAD
Manufacturer
IVOCLAR USA, INC.
Date Cleared
1998-05-11

(55 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

Intended Use: ProCad is intended to be used for inlays, onlays, veneers, and anterior/posterior crowns.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device called "ProCad". It does not contain information about acceptance criteria, study details, or performance data for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its intended use, which are "inlays, onlays, veneers, and anterior/posterior crowns."

§ 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.