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K Number
K013198
Device Name
FUJI VII CAPSULE
Manufacturer
GC AMERICA, INC.
Date Cleared
2001-10-29

(34 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

GC Fuji VII is a capsulated restorative glass ionomer cement intended. for :

  • Treatment of early non-cavitated Icsions; such as tooth brush . abrasion and Root surface sensitivity.
  • Pit and Fissure Sealant .
  • · Intermediate restorative material
  • · Temporary filling of endodontic access
Device Description

GC Fuji VII is a capsulated restorative glass ionomer cement.

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental device called "Fuji VII Capsule." This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria. The 510(k) pathway often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical trials with predefined acceptance criteria.

§ 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.