LogoFDA 510(k) Search
K Number
K980682
Device Name
FUJI II
Manufacturer
GC AMERICA, INC.
Date Cleared
1998-04-03

(39 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Fuji II is a self-cure glass ionomer material intended for the use as a dental restorative for the following typical applications:

  • Restoration of primary teeth.
  • Core build-ups.
  • Class III, V and limited Class I cavities.
Device Description

Fuji II is a self-cure glass ionomer material.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a dental restorative material called "Fuji II". This document confirms the device's substantial equivalence to a predicate device and allows it to be marketed.

However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

The letter only states:

  • Trade Name: Fuji II
  • Regulatory Class: II
  • Product Code: EMA
  • Indications For Use: Restoration of primary teeth, Core build-ups, Class III, V and limited Class I cavities.
  • Substantial Equivalence: The FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.

To answer your request, information regarding performance data, testing methods, sample sizes, ground truth establishment, or expert involvement would need to be found in the actual 510(k) submission document itself, which is not provided here. The clearance letter only references the submission and its outcome.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.