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K Number
K991844
Device Name
PRO-GLASS
Manufacturer
CAD CAM VENTURES
Date Cleared
1999-07-21

(54 days)

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

The indicated usage for this product is as a machinable ceramic for use in the construction of ceramic Fixed Restorations.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a dental device called "Pro-Glass." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

The document does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the provided input.

§ 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.