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K Number
K132748
Device Name
BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2013-12-04

(92 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

BEAUTIFIL e Posterior / BEAUTIFIL Bulk comes in 28 shades, among which Universal and A shade (given the trade name BEAUTIFIL Bulk) provide high transparency and greater depth of cure by reducing pigment content compared to other shades. Universal and A shade (BEAUTIFIL Bulk) are intended only for direct posterior restorations.

BEAUTIFIL e Posterior
(Indications)

  • Direct posterior restorations .
  • Repair of restorations and prostheses ●

BEAUTIFIL Bulk
(Indications)
Direct posterior restorations using a light-curing resin paste to be used for masking the substructure color of dental restorations.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a correspondence from the FDA regarding the 510(k) clearance of the "BEAUTIFIL e Posterior / BEAUTIFIL Bulk" dental device. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

The document primarily focuses on the FDA's "substantial equivalence" determination to legally marketed predicate devices, meaning it allows the device to be marketed. It does not include the detailed technical study information you are asking for.

§ 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.