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K Number
K965216
Device Name
ARGI-SATIN OR OPTI0-STAR
Manufacturer
ARGEN PRECIOUS METALS, INC.
Date Cleared
1997-02-27

(59 days)

Product Code
ELL
Regulation Number
872.3920
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 872.3920 Porcelain tooth.

(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.