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K Number
K032416
Device Name
VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2004-02-05

(184 days)

Product Code
EIH
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

Vintage Press, Vintage LF and Vintage LF Stain are dental porcelain system used for fabricating restorations (all ceramic crown and/or metal ceramic crown), build up on a ceramic substructure and/or on a metal substructure .

Device Description

Vintage Press, Vintage LF, Vintage LF Stain Dental Ceramic

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental ceramic product. It is a regulatory approval document and does not contain information about acceptance criteria or performance studies for an AI/ML powered device. Therefore, I cannot provide the requested information.

§ 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.