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K Number
K020117
Device Name
GC FUJI LINING LC PASTE PAK
Manufacturer
GC AMERICA, INC.
Date Cleared
2002-02-28

(45 days)

Product Code
EMA,EJK
Regulation Number
872.3275
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 Lining LC Paste Pak is intended to be used as a base or liner in prepared cavities.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "GC Fuji LINING LC PASTE PAK" device. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices.

The letter explicitly mentions that the device is a "Calcium Hydroxide Cavity Liner" intended to be used "as a base or liner in prepared cavities."

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or groundbreaking studies related to AI or human improvement.

The letter is a regulatory approval document based on substantial equivalence to existing devices, not a scientific study report. Therefore, I cannot provide the requested information from this document.

§ 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.