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K Number
K140512
Device Name
UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
Manufacturer
JUNO DENTISTRY LP
Date Cleared
2014-07-02

(124 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K120453
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

UFill Bulk Fill Posterior Flowable Composite is indicated for use (i) in fillings with layer thicknesses up to 4mm in Class I and II cavities, (ii) in cavity lining- as a first (bottom layer) in Class I and II cavities.

Device Description

UFill Bulk Fill Posterior Flowable Composite is a light cure radiopaque posterior composite for use in the Bulk-Fill Technique. The flowable viscous material is suitable for filling layers of up to 4mm in thickness and as a cavity lining (bottom layer) for both Class I and II restorations. Placed in a unit dose needle capsule containing 0.25g of material, the device is delivered by a standard dental unit-dose tip applicator dispenser gun, and offered in a universal dentin shade that is formulated and manufactured without Bis-GMA, HEMA, or TEG-DMA.

AI/ML Overview

The provided document describes the "UFill Bulk Fill Posterior Flowable Composite" and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that uses human experts to establish ground truth for a test set, nor does it discuss AI or machine learning. The device is a dental restorative material, and the performance testing mentioned is physical testing per ISO 4049-2009.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on material composition, intended use, and physical properties, not on diagnostic performance or human-AI interaction.

The information present in the document is limited to:

  • Device Description: A light-cure radiopaque posterior composite for bulk-fill technique.
  • Predicate Device: 3M-Filtek Bulk Fill Flowable Restorative (K120453).
  • Indications for Use: Fillings with layer thicknesses up to 4mm in Class I and II cavities, and as a cavity lining (bottom layer) in Class I and II cavities.
  • Technological Characteristics: UDMA and BDDMA as resin components, silanized strontium aluminum boron silicate glass and silanized silica fillers (approx. 77% by weight), light-activated cure.
  • Performance Testing: "Physical testing per ISO 4049-2009, Dentistry -- Polymer-based restorative materials was conducted with all criteria for success satisfied."
  • Safety Testing: Evaluated per AAMI/ANSI/ISO 10993-1:2009.
  • Risk Management: Evaluated per ISO 14971:2007.

The comparison table outlines characteristics like intended use, basic material composition, method of cure, delivery system, shade, depth of cure, and performance characteristics (radiopaque, flowable, compliant to ISO 4049).

None of these sections address AI, expert evaluations, ground truth establishment with human experts, MRMC studies, or standalone algorithm performance.

§ 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.