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510(k) Data Aggregation
K Number
K172952Device Name
Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit
Manufacturer
Date Cleared
2018-07-03
(280 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Figaro Crowns, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Figaro Preformed Dental Crown is intended for restoration of permanent teeth with a single unit crown.
The Figaro Crowns are intended for restoration of permanent adult teeth with a single unit crown.
Device Description
The Figaro Crown is a permanent preformed resin crown used on adult patients. The crown is designed for permanent (>30 days) tooth restoration to restore, size, strength, chewing ability and for to improve appearance. The preformed crowns are manufactured to specific sizes for improved fit. The crowns go through a finishing process and are not intended to the manipulated by the dentist. Sizing is exclusively determined by the dentist for each crown and patient. The crown is secured to the patient's mouth with standard adhesion techniques. Once the crown is cemented in place it should fully encase the portion of the tooth that lies above the gum line. The Figaro Preformed crown is made of layers fiberglass held together by epoxy resin. Small amounts of Titanium Dioxide and Yellow Iron oxide are added for cosmetic affect.
The crowns are designed for the following designs, Canine, Upper Premolar, Upper Molar, Lower Premolar, Lower Molar. The crowns are provided in one size.
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