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K Number
K012735
Device Name
CLEARFIL DC CEMENT
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-14

(31 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K980232
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CLEARFIL DC CEMENT is indicated for the following applications:

  • Porcelain inlay cementation 1)
  • Composite resin inlay cementation 2)
  • Jacket crown cementation with porcelain or composite resin 3)
Device Description

CLEARFIL DC CEMENT is a dual-cure composite resin cement and used as a cement to affix dental appliances such as crowns. This product is classified into the dental cement other than zinc oxide-eugenol, 21 C.F.R. Section 872.3275.

AI/ML Overview

The provided document is a 510(k) summary for a dental device, "CLEARFIL DC CEMENT." This document focuses on a change in manufacturer and asserts that the device is "substantially equivalent" to a previously cleared predicate device (K980232).

Crucially, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data analysis.

The 510(k) submission states that: "This device is essentially the same as CLEARFIL DC CEMENT manufactured by Kuraray Co., Ltd. (K980232). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL DC CEMENT." This implies that the performance data from the predicate device's clearance would be referenced, but no such data, acceptance criteria, or study details are present in this specific document.

Therefore, I cannot provide the requested information from this document. If these details were available, they would typically be found in sections describing performance testing, clinical studies, or bench testing results which are absent here.

§ 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.