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K Number
K062410
Device Name
CLEARFIL ESTHETIC CEMENT & DC BOND
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2006-09-26

(40 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K032455,K012735,K043177
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, hybrid ceramics, composite resin or metal
    1. Cementation of veneers
    1. Cementation of adhesion bridges
    1. Cementation of metal cores, resin cores, metal posts or glass-fiber posts
Device Description

CLEARFIL ESTHETIC CEMENT & DC BOND

AI/ML Overview

The provided text is a 510(k) Summary for a dental cement product, CLEARFIL ESTHETIC CEMENT & DC BOND. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

Instead, the document focuses on:

  • Identification of the device and applicant.
  • Identification of predicate devices used to establish substantial equivalence.
  • Indications for Use of the device.
  • FDA's 510(k) clearance letter, stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. The document is primarily a regulatory filing for market clearance, not a performance study report.

§ 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.