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K Number
K980232
Device Name
CLEARFIL DC CEMENT
Manufacturer
KURARAY COMPANY, LTD.
Date Cleared
1998-02-24

(33 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
    1. Porcelain inlay cementation
    1. Composite resin inlay cementation
    1. Jacket crown cementation with porcelain or composite resin
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental cement product called "CLEARFIL DC Cement." This document does not contain information about acceptance criteria or a study proving device performance.

510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not on meeting specific performance criteria demonstrated through clinical studies in the same way a PMA (Premarket Approval) would require. The letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) from the provided document. This type of information would typically be found in a separate study report or regulatory submission, not in the FDA clearance letter itself.

§ 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.