(280 days)
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.
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.
The provided text is a 510(k) premarket notification for Figaro Crowns Anterior Crown Kit and Figaro Crowns Posterior Crown Kit. It discusses the device's description, indications for use, comparison to a predicate device (K143694 Rhondium One-Visit-Crown (OVC)), and non-clinical performance testing.
However, it does not contain any information about acceptance criteria for performance metrics, the results of a study proving the device meets those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert involvement, or adjudication methods. The non-clinical performance testing listed (Flexural Strength, Flexural Modulus, Tensile Strength, Tensile Modulus, Charpy Index) are material property tests, not clinical performance studies with acceptance criteria relevant to the clinical efficacy or safety of the device in a human-in-the-loop or standalone AI context.
Therefore, I cannot fulfill your request for the specific information points as they are not present in the provided document. The document primarily focuses on demonstrating substantial equivalence based on indications for use, technology, materials, and generic material property testing rather than clinical performance acceptance criteria and studies.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.