LogoFDA 510(k) Search
K Number
K024250
Device Name
MATCH PRESS PRESSABLE CERAMIC
Manufacturer
DAVIS SCHOTTLANDER & DAVIS, LTD.
Date Cleared
2003-08-25

(245 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

Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification approval letter for a dental device. It does not contain information about acceptance criteria, device performance metrics, or study details as requested. The content is an FDA regulatory approval, not a scientific study report.

Therefore, I cannot provide the requested information based on the given text.

§ 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.