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K Number
K180803
Device Name
BeautiBond Universal
Manufacturer
Shofu Dental Corporation
Date Cleared
2018-09-26

(182 days)

Product Code
KLE,EBF,EMA
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Direct restorations with light-cured composite resin
  • Repairs of fractured restorations with light-cured composite resin
  • Cementation of indirect restorations with light- or dual-cured resin cement
  • Core build-up with light- or dual-cured core materials
Device Description

Not Found

AI/ML Overview

The provided text is related to an FDA 510(k) clearance for a dental bonding agent called "BeautiBond Universal". It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

  • Trade/Device Name: BeautiBond Universal
  • Regulation Number: 21 CFR 872.3200
  • Regulation Name: Resin Tooth Bonding Agent
  • Regulatory Class: Class II

The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of study detailed in the request. For a Class II device like this bonding agent, substantial equivalence is typically established by comparing the device's technological characteristics and performance data to that of a predicate device. This usually involves bench testing (e.g., bond strength, cytotoxicity, biocompatibility) rather than studies with expert readers, AI, or ground truth as described in the prompt.

Therefore, I cannot provide the requested information based on the given text. The text does not detail:

  • Acceptance criteria table or reported device performance against such criteria.
  • Sample sizes for test sets or data provenance.
  • Number/qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness study or effect sizes of human readers with/without AI.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for training set.
  • How ground truth for the training set was established.

This is a regulatory clearance document for a physical medical device, not a software or AI-powered device, hence the absence of such information.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.