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K Number
K993973
Device Name
FUJI II LC CAPSULE
Manufacturer
GC AMERICA, INC.
Date Cleared
2000-01-11

(49 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Class III and V restorations; particularly areas of cervical erosion, a. abfraction lesions and root surface caries.
  • Restoration of primary teeth b.
  • As a base or liner C .
  • Core build-ups/block-outs (particularly of vital teeth) ర .
  • Cases in which a radiopaque restoration is required e .
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. The document is an FDA 510(k) clearance letter for the Fuji II LC Capsule, which is a dental material. It confirms that the device is substantially equivalent to a legally marketed predicate device and lists its indications for use.

Therefore, I cannot extract any of the requested information regarding acceptance criteria or a study proving device performance from this document.

§ 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.