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K Number
K981514
Device Name
GC FUJI BOND LC
Manufacturer
GC AMERICA, INC.
Date Cleared
1998-06-16

(49 days)

Product Code
KLE
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

GC Fuji BOND LC modified is a dentin/enamel bonding material used to restore all cavities Class I, II, III, IV and V in combination with a light cured composite resin.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot extract any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a product named "GC Fuji BOND LC Modified." This letter states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework for its marketing.

The only relevant sections in terms of product claims are the "Indications for Use" statement, which specifies that "GC Fuji BOND LC modified is a dentin/enamel bonding material used to restore all cavities Class I, II, III, IV and V in combination with a light cured composite resin." However, this section does not detail acceptance criteria or present any study results.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication method.
  5. Information about MRMC comparative effectiveness studies or effect sizes.
  6. Information about standalone performance studies.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.